Physician s Clinical Guideline

Transcription

1 The First Multi-Functional Fractional CO 2 Laser System Physician s Clinical Guideline Skin Laxity Rhytide / Wrinkle Reduction Scars / Micro Fractional Resurfacing

2 Resounding in Excellence The eco2 laser is the newest generation of CO 2 fractional resurfacing that combines all the innovative concepts of fractional technology with the deep ablative properties of a CO 2 laser nm wavelength has a high absorption rate to water. Therefore, tissue ablation and shrinkage occurs when CO 2 fractionated laser beams penetrates the skin. Narrow Micro Ablative Columns of eco2 system penetrate deeper into the skin with maximum depth of 2.5mm reducing epidermal damages. It forms small necrotic area and reduces lateral heat damage. When compared with similar CO 2 fractional laser systems, eco2 does not cause any side effects. eco2 remodels collagen within the reticular dermis, dramatically improving scars and uniformly resurfacing the skin surface with minimal downtime and rapid recovery. eco2 offers multiple functionalities to cater to the needs of each individual patient. eco2 has incorporated features to make it easier for physicians to treat various indications, different skin types and its responses. Users can treat various indications with the most sophisticated fractional laser system today. T-1

3 The First Multi-Functional Fractional CO 2 Laser System T-2

4 INDEX 1. Introduction 1.1. Fractional CO 2 Laser Skin Resurfacing 1.2. eco2 Introduction 1.3. The Outstanding Features of eco2 2. eco2 Treatment Protocols 2.1. New 321 treatment technique What is the 321 treatment technique Diffentiation priority of treatment of eco Various Tips Effective treatment with 3 stages 2.2. Skin Rejuvenation Skin Laxity (Deep Wrinkles) Large Pores & Fine Wrinkles Uneven Skin Tone Non-facial Areas (Neck, Chest, & Hands) 2.3. Scars Acne Scar Burn Scar Hypertrophic Scar & Keloid Atrophic (Linear) Scar Striae Distensae 2.4. Nevus, Syringoma, & Wart 2.5. Fractinonal CO 2 Resurfacing with the 1000tip 2.6. Skin Delivery eco2 treatment with Botox eco2 treatment with TCA eco2 treatment with Bledomycin 2.7. Combination Therapy of eco2 and MOSAIC T-3 Lutronic Corporation All Rights Reserved

5 3. Pre Operative Care 3.1. Pre-Treatment Instructions 3.2. Contraindications & Possible Complications 3.3. Treating Sensitive Areas 3.4. Cautions for eco2 Operation 4. Post Operative Care 4.1. Postoperative Skin Reactions 4.2. Post-Treatment Instructions 4.3. FAQ 5. General Operating Guide 5.1. Parameter Setting 5.2. Operational Mode Setting 5.3. General Treatment Protocol 5.4. Additional Operational Options 6. Appendix 6.1. Laser Safety 6.2. Handpiece Usage and Maintenance 6.3. eco2 Micro-Fractional Skin Resurfacing (Pre-Treatment Considerations/ Consent Form / Post-Treatment Considerations) 6.4. Patient Treatment Chart 6.5. Treatment Parameter Guideline DISCLAIMER Registration, licensing and/or approval of medical lasers are required in many countries and jurisdictions. Operators should be fully aware that not all of the protocols in this internationally-issued manual are approved in their country. It is the responsibility of the operator to check with their government as to which indications are locally approved for treatment. Lutronic Corporation does not advocate specific laser parameters or treatment guidelines. The following information has been complied by suggestions from international physicians who are experienced in using fractional CO 2 lasers. The information provided in this guide should not be used as a primary source for determining treatments. Lutronic Corporation shall have no liability whatsoever for consequential, incidental or punitive damages arising out of the sale, installation, or improper use of eco2 Laser System. It is essential that all medical staff using the technology be appropriately educated. A fractional laser course includes didactic lecture on: laser physics, laser safety, and hands-on sessions. Live patient observation followed by preceptorship is highly recommended. For more information on training courses, contact your sales representative or edu@lutronic.com. Operators should seek continuing education in fractional cases and are strongly advised to consult medical journals specific to their practice to ensure clinical updates on existing and new treatment procedures. T-4

6 eco2 TM Ablative CO 2 Fractional Laser This clinical protocol offers an overview of the basic operation guidelines for ablative fractional treatment procedures using eco2 laser system. The Clinical parameters and operation techniques have been developed based on recommendations from physicians who use the eco2 laser system and they are to be used as a guide only. Continuing laser education and experience should be sought in order to assure ensure full competency. Please note that with each indication a wide range of treatment parameter settings is guided. Since each clinical situation is unique, choosing the appropriate energy setting and total density is primarily determined by the patient s ethnicity, skin type and sensitivity. Caucasian patient with skin type I or II can endure higher energy and density compared to skin Type III to VI Asian, Hispanic, Indians and black patients. Understanding the patient s etiology and medical background will produce remarkable results, minimize side effects and enable you to have a successful practice. Finally, sufficient skin cooling reduces pain and PIH. Applying cooled air, ice pack or a contact cooler during the procedure can increase patient s comfort significantly when higher energy levels are used. T-5 Lutronic Corporation All Right Reserved

7 Clinical Indication 1) Skin Rejuvenation Skin Laxity (Deep Winkles) Large Pores Fine Wrinkles (Periorbital, Perioral) Uneven Skin Tone (Pigments, Telangiectasia) Off-Face (Neck, Chest, & Hands) 2) Scar Acne Scar Burn Scar Hypertrophic Scar Keloid Atrophic Linear Scar Striae distensae * FDA Clearance (510(k) No. : K080496) - Wrinkles - Rhytides - Furrows - Fine lines - Textural irregularities - Pigmented lesions - Vascular dyschromia 3) Nevus, Syringoma, & Wart System Specifications Wavelength CO 2 10,600 nm Laser Category Ablative CO 2 fractional Laser Power eco2 Premium : 5, 10, 15, 20, 25, 30 W, (Adjustable) eco2 Standard : 30W, Fixed Dual Operation Mode Dynamic /Static Pulse Energy 240 mj Adjustable Spot Size Min. 120 µm / 300 µm Max. 1 mm (Supplied only for eco2 Premium) Ablation Depth Up to Max 2.5 mm Frequency (Dynamic Mode) Hz Density (Static Mode) 400 spots/cm 2 Scan Area Size Max. 14 x 14 mm Scan Shape (Dynamic Mode) Square Shape / Point Beam Scan Shape (Static Mode) Square, Rectangular, Circle, Triangular Shape Handpiece Tips 120 / 300 / 500 / 1000 (Optional) Dual Beam Pattern Chaos (Random) / Normal (Regular) Beam Delivery Method Non-sequentially Placed Beams Multiple Repetition Mode (Stacking Mode) Display Single, Multiple (2-5 shots) Touch Screen w/ Flash Technology: 7 LCD Dimensions(*Excludes Arm) 360 mm (W)x450 mm (L)x1870 mm (H) Weight 48 Kg T-6

8 1. Introduction 1.1 Fractional CO 2 Laser Skin Resurfacing The well established CO 2 Laser resurfacing has been the gold standard in skin resurfacing for the past couple decades as it achieved unparallel smoothness and reduction of wrinkle or scar that no other modality matched. However, this treatment has now fallen out of favor because of significant pain requiring local anesthesia and substantial down time with the complexion appearing edema and erythema for at least couple of weeks. 1.1 More recently the new CO 2 fractional ablative lasers have been developed which actually removes the heated column of the skin tissue with micro laser beams and provides a more substantial wrinkle removal and superficial skin tightening than the non-ablative fractional lasers. This fractionated CO 2 laser technology delivers microscopic beams of 10600nm CO 2 laser energy across the skin s barrier, resurfacing 10-40% of the skin s surface area in one session. These new ablative fractional CO 2 lasers have the advantage of producing better wrinkle removal and skin rejuvenation than the non-ablative fractional lasers with less down time than the traditional non-fractional ablative CO 2 and Erbium lasers. 1. Introduction With fractional CO 2 laser resurfacing, the laser beam is fractionated into many small micro beams when they target the skin, the small areas of the skin between the beams are not lased and left intact. These untreated surrounding skin promote a much more rapid recovery and healing with less risk of complications. Each areas treated by the fractional micro beams, called micro ablative columns, causes sufficient laser injury to promote new collagen production and resultant facial skin rejuvenation. The growth of collagen results in skin that continues to improve over the next 3 to 6 months. CO 2 Fractional Laser Resurfacing reduces fine lines, wrinkles, noticeably improves skin tone, texture, large pores and causes immediate skin tightening. The high energy beam targets wrinkles, pigmentation issues, texture problems, and acne scars. Lutronic Corporation All Right Reserved

9 1.2. eco2 Introduction The eco2 laser system is a newly-upgraded CO 2 fractional laser system with a wavelength of 10,600nm which combines clinical advantages of the conventional Ablative Skin Resurfacing(ASR) and the safety of the Fractional Photothermolysis. CO 2 laser wavelength has a high absorption rate to the intra/extracellular water. Such high absorption of CO 2 radiation causes vaporization of the tissues, and this characteristic has been applied to the conventional CO 2 Ablative Skin Resurfacing in the past years. However, this treatment has limitations such as prolonged recovery period and a higher risk for side effects. Since CO 2 laser ablates, in which the skin tissue is surgically removed, it creates open wounds and severe adverse effects are easily induced. In order to overcome these problems, Lutronic Corporation has applied a new theory called, Fractional Photothermolysis to the conventional CO 2 laser system, creating a newlyupgraded CO 2 ablative fractional laser system called, eco2. The most outstanding characteristics of eco2 treatment is that the coverage percentage of the treatment area is relatively low such as less than 20%, thus more than 80% of the treatment area is left intact. This new approach remarkably reduces prolonged downtime and side effects which are the most common complaints after conventional CO 2 Ablative Skin Resurfacing, while still achieving dramatic clinical effects Introduction Laser Tissue Absorption Spectrum

10 1. Introduction Ablative CO 2 Fractional Laser - Skin Tissue Interaction Numerous micro-sized vaporizations, called Micro Ablative Columns (MACs), are formed when eco2 laser beams out in the hundreds of micro laser beams per unit area (1cm 2 ). Immediately after an eco2 treatment, these Micro Ablative Columns (MACs) shows a figure like numerous pinpoin holes on the surface of the treated area Introduction As the eco2 fractional micro laser beams penetrate into the deep dermis, Micro Ablative Columns are created. The Micro Ablative Columns varies in both depth and width according to the selected Pulse Energy level. The maximum penetration depth is 2.5mm, however the width is less than 300um. In addition, each Micro Ablative Column is surrounded by a narrow necrotic layer approximately less than 100um which promotes coagulation and collagen shrinkage. Within 48 hours after an eco2 treatment, re-epithelialization process is complete, and the epithelial debris is found at the stratum corneum. Newlyproliferated keratinocytes from the stratum basale slowly moves toward stratum corneum, thus normalizing the whole epidermis. At the same time, Micro Ablative Columns are slowly re-filled through new collagen formation. In general, skin tone improves once epidermal debris has completely fallen away. And Long-term dermal remodeling progresses for the next 3-6 months. The relatively narrow width of Micro Ablative Columns promotes rapid wound healing process and less PIH chance. eco2 system can efficiently improve a variety of scars, wrinkles, photo-aging skin, and uneven skin tone, promoting total skin rejuvenation as well. CO 2 Microscopic laser beam create MACs Re-epithelialization & Collagen Remodeling Fig 1.2 Micro Ablative Column Lutronic Corporation All Right Reserved

11 Expected Results from eco2 Treatment * Immediate Tightening of Skin : Immediate contraction of collagen reduces wrinkles and loose skin. Skin laxity is noticeably improved. * Textural Improvement : Ablation and reconstruction of new collegen formation. : Reduction of pore size, wrinkles, acne scars and other textural irregularities. * Effective on Superficial Pigmented Lesions : Ablation pigmented skin tissue. : Effective on dyschromia (discoloration from sun damage and aging) and irregular skin tone * Rare Occurrence of PIH : Even in skin type III-V, no PIH is induced. * Minimal Down Time : The remarkable result of the eco2 fractional technique makes the healing process much quicker and enables patients to get back to their normal life style sooner Introduction 55mJ Immediate After Post 2 days 55mJ Post 7 days Post 2 weeks 55mJ 55mJ Histological Slides of Wound Healing Process

12 1. Introduction 1.3. The Outstanding Features of eco2 *Minimized Beam Size A CO 2 fractional laser systems satisfying clinical outcome is achieved by its minimized size of the laser beam. The eco2 delivers a beam size so small that it measures less than 120um, yet still achieves a deeper penetration compared to other CO 2 fractional systems at the same pulse energy (or pulse width). Therefore, it creates minimal ablated width and thinner necrotic layer surrounding Micro Ablative Columns, reducing lateral heat diffusion compared to other CO 2 fractional laser systems. Additionally, eco2 provides 300 microns and 1000 microns beam size for flexible approach to different indications Introduction *Controlled Chaos Technolgoy TM eco2 is equipped with a patented technology called, CCT(Controlled Chaos Technology ). CCT radiates micro laser beams in a random spray pattern which lessens the patient s discomfort and promotes a more natural clinical outcome. At the same time, the eco2 system still provides a regularized beam pattern in addition to its Controlled ChaosTechnology for users who may prefer the regular beam pattern of other similar laser devices. Controlled Chaos Technology *Dual Mode (Static & Dynamic) eco2 laser system is the first medical laser device equipped with a dual operation modes, the Static Mode and the Dynamic Mode. In the Static Mode the number of laser beam radiation varies respectively to the selected density set for a unit area (1cm 2 ); conversely in the Dynamic Mode, the laser beams are continuously radiated as the hand piece moves across the treatment area. Operators can freely switch between these two modes and efficiently combine both in one session of treatment. It is recommended to treat with the Static Mode first, followed by the Dynamic Mode for a feathering effect, which creates a more natural clinical outcome than when treating only with the Static Mode. Dual Operation modes The Static mode TheDynamic mode Lutronic Corporation All Right Reserved

13 *Scan Types & Handpiece Tips eco2 has easy switching Scan Type button on the handpiece as well as on the screen to choose various shapes and sizes of laser scanning-type. These various scan types optimizes access to the treatment area with various contours and shapes of skin surfaces such as square, circular, triangular, rectangular, and point beam with different sizes accordingly. The point beam delivers only one single laser beam, and this can be effectively used in the removal of nevus, syringomas and wart. eco2 provides various handpiece tips with different beam sizes (120, 300, 1000 micron) for variable indications. Using a tips with a skin sensors, physician are able to reduce operating time. And does not need to press foot pedal repetitively. Handpiece & Tips Control with your finger tips : adjust scan type and scan size Changeable Tip No Cousumables! 120 Tip 500 Tip 1. Introduction 300 Tip * Variable Peak Energy The eco2tm Premium model can adjust peak power according to various indications. (5W, 10W, 15W, 20W, 25W, 30W) High peak power means short pulse duration at same pulse energy compared with a lower power setting. Because short pulse duration can deeply ablate skin tissue and the surrounded necrotic wall of MAC is narrow, a high peak power is proper for acne scars. When targeting wrinkles, a low power setting is recommended for more efficient thermal effect. Note. This feature is available for eco2 Premium model * Multiple Stacking Mode eco2 laser system is also equipped with a unique function - Repetition Mode (also called Multiple Stacking Mode). This technology automatically delivers several successive beams into the same micro-ablated hole. It can be used as pinhole method using conventional CO2 laser. This unique mode provides an additional treatment choice.

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15 2. eco2 Treatment Protocols 2.1. New 321 treatment technique What is the 321 treatment technique Diffentiation priority of treatment of eco Various Tips Effective treatment with 3 stages 2.2. Skin Rejuvenation Skin Laxity (Deep Wrinkles) Large Pores & Fine Wrinkles Uneven Skin Tone Off-Face (Neck, Chest, & Hands) 2.3. Scars Acne Scar Burn Scar Hypertrophic Scar & Keloid Atrophic (Linear) Scar Striae Distensae 2.4. Nevus, Syringoma, & Wart 2.5. Fractinonal CO2 Resurfacing with 1000tip 2.6. Skin Delivery eco2 treatment with Botox eco2 treatment with TCA eco2 treatment with Bledomycin 2.6. Combination Therapy of eco2 and MOSAIC

16 2. eco2 Treatment protocols 2.1 New 321 treatment technique What is the 321 treatment technique? This is a new treatment technique exclusively developed for Lutronic s eco2 laser to achieve absolutely the best clinical effects in skin rejuvenation through using a combination of different tips and their beam sizes in tandem with varying other parameters such as spot density and pulse energy. With lasers in general, it s always better to start low and work high, and that s exactly what the eco step protocol achieves, so that patients can get the wow factor from the very first session eco2 Treatment Protocols Each treatment protocol is subdivided into 2 or 3 sessions, depending on the entity being treated and its severity, and uses a different treatment tip. The table below gives treatment guidelines for mild to more seriously damaged skin. The first session with a large tip and treatment area treats the skin gently and superficially, toning the target skin and improving the outward appearance immediately while preparing it for the next session. This is followed in the subsequent 2nd and 3rd sessions by a combination of more intense parameters with successively smaller tips to give more aggressively deep treatments. Two weeks is the interval between sessions, as by this time healing is complete, and the entire protocol delivers increased treatment efficacy with dramatically reduced downtime. Patients are unique, each with their own particular problems, for example large pores, fine lines, wrinkles or acne scarring. Some patients may have a combination of problems, and certainly even in the same patient the severity of the same problem may differ depending on the area involved. That s why the inter-dependent parameters of the step protocol were developed for the eco2: to allow for true tailor-made treatment of patients and their conditions in a safe, flexible but powerful protocol, minimizing pain, downtime and the potential for unwanted side effects such as post-inflammatory hyperpigmentation, while maximizing treatment results and of course patient satisfaction. Uneven skin tone Large pores, Rough skin, Wrinkles eco Step operation protocol 1st Session Tip 500 Pulse energy 6 ~ 10 mj Density 100 ~150 2nd Session Tip 500 or 300 Pulse energy 10 ~ 20 mj 3rd Session Density 100 1st Session 2nd Session 3rd Session Tip 500 Pulse energy 6 ~ 10 Density 100 ~150 Tip 300 Pulse energy 20 ~ 30 mj Density 100 Tip 120 Pulse energy 30 ~ 50 mj Density 100 coverage > 15% Induce remodeling of superficial dermal layer with a more aggressive approach than the first session coverage > 15% Treat whole face with a more aggressive approach than the first session Strongly approach the area around the eyes, mouth with heavy wrinkles using a 4*4 mm scan size. Acne scars, Skin laxity, Deep wrinkles 1st Session Tip 300 or 500 Pulse energy 6 ~ 10 mj Density 100 ~150 2nd Session Tip 120 Pulse energy 50 ~ 90 mj 3rd Session Density 100 coverage > 15% Induce remodeling of superficial dermis layer with a a more aggressive approach than the first session

17 1st Session advantages 1:Dramatic improvement of skin tone immediately after treatment, due to gentle toning with the large beam size 2:Crusting is microscopic, and almost impossible to see with the naked eye. Even though the eco2 is an ablative laser, at this setting the microablative zones (MACs) are restricted to the epidermis, and hardly involve the dermis. This has the effect of a mild stratum corneum peel, leaving the skin surface smooth and luminous. 3:No anesthetic is required because this microsession is very superficial, thus hardly triggering any pain impulses from the peripheral sensory nerve endings 4:Slight erythema will evolve naturally within 1 week at the latest 5:Prepares the skin for the second session Diffentation priority of treatment of eco2 Smaller Beam Size & HIGH ENERGY Penetrate deeply in dermal layer Larger Beam Size & LOW ENERGY Weakly ablate epidermal layer 2-2 scar, wrinkles, laxity Skin tightening + Collagen remodeling Major serious skin reaction, downtime (erythema could last for 1 month), pain (pain and downtime are able to be overcome by adjustment of scan size) Tips (120, 300, 500, 1000 micron beam size) skin tone, texture, pores, fine wrinkles Alike to efficacy of slight chemical peeling Minor skin reaction, less downtime, no anesthesia. (does not high energy to penetrate into dermis) 2. eco2 Treatment Protocols 120 Tips Skin Sensor 300 Tips Deeper MAC created 500 Tips Superficial Resurfacing

18 2. eco2 Treatment protocols eco2 TM 120 Tip Vs 300Tip : Penetration depth and width of each tipusing the same parameter (Courtesy of Won-Serk, Kim M.D) eco2 Treatment Protocols 120 tip : 22 mj Depth : 342 μm Width : 100 μm Deeper Penetration Penetration depth and Indications of each tips (Micro spot size) 300 tip, 22 mj Depth : 285 μm Width : 289 μm Wider and Superficial Ablation 500 Tip 300 Tip 120 Tip Shallow Penatration Deeper Indication Skin Tone Fine Wrinkles Large Pores Atropic Scar Skin Laxity

19 eco treatment - Effective treatment with 3 stages 3:MS (Micro Spot) 500 tip 2:SMS (Super Micro Spot) 300 tip 1:UMS (Ultra Micro Spot) 120 tip Big 500 μm spot size, wide % coverage Enrich thermal effect win the superfi- The deepest penetration session: the remove epidermal pigmented lecial dermal layer by deeper penetration penetration depth of 2.5 mm into the le- sions and resurface entire skin tone compared to the first session sion induces active collagen remodeling immediately. Induce rejuvenation of epidermis and Improves bulk scar, deep wrinkles Efficacy for immediately skin tightening dermis, stimulate wound healing In spite of deep penetration, use of the Little pain, short down time Collagen remodeling for large pores 120 μm beam minimizes side effects, Patients adapt following treatment with wrinkles reduces down time. UMS SMS MS UMS SMS MS UMS sms MS eco2 - Every time 3 step complex treatment protocol for all acne scars Acne scar point : 120 tip, 4*4 mm scan size >50 mj (1mm ablation depth) 100 spots/density x2passes (<15% coverage) 2. eco2 Treatment Protocols Surrounding skin or full face : 300 tip, 12*12 mm scan size < 30 mj(superficial ablation) 100 spots/density, 1pass (>15% coverage) You are advised to treat the acne scars individually and deeply in the dermal layer with the 120 tip (stamp mode, small pink squares) and then treat the scars and their surrounding tissue lightly with the 300 tip (stamp mode, larger white squares). Finally, use the 300 tip in dynamic mode to feather the treated area in with the surrounding skin (yellow line) Feathering (free handling) Dynamic mode <30 mj, 60~80 Hz

20 2. eco2 Treatment Protocols 2.1. Skin Rejuvenation Skin Laxity (Deep Wrinkles) Beam Size ( μm ) Peak Power (W) Mode Pulse Energy (mj) Total Density (spots/cm 2 ) No. of Passes Treatment Interval No. of Sessions 120 or Static ~30 50~100 1 passes 4~6 weeks eco2 Treatment Protocols < Treatment Guidelines > * In Static Mode, it is recommended to use 30-60mJ of energy with a density of spots/cm 2 per pass of treatment for skin type III-V. * Skin type I or II can be treated with a higher pulse energy from100mj to140mj and more aggressive total density of 100 spots/cm 2 with 2 passes. There should be no concern for the risk of PIH or burn for fair skins. * 1-2 passes is generally recommended. If expected total density is 100 spots/cm 2, select the density of 50 spots/cm 2. 1pass treatment with 50% overlapping of the adjacent scar area will reach 100 spots/cm 2 total density per each square centimeter. Another treatment method is to select 100 spots/cm 2 density and treat without overlapping adjacent scar area. The former method causes less thermal damage. * After treating in the Static Mode, switch to the Dynamic Mode. In the dynamic mode, mainly target border line or adjust the pulse energy down to 20-30mJ according to skin type. * By combining the Dynamic Mode and the Static Mode, demarcated borders will be reduced and generate a more natural clinical result. Therefore, natural clinical results can be expected. * Erythema with sunburn symptoms will persist for 1 to 3 days post treatment, but this will completely disappear within a week. * Mild pinpoint bleeding might occur immediate or until 1 day after eco2 treatment. This is a normal skin response caused by the deep penetration of laser beams. Pre-Tx Post 2 nd Tx Courtesy of K.T.Hong, M.D Korea Lutronic Corporation All Right Reserved

21 Pre-Tx Post 1 st Tx Courtesy of K.T. Hong, MD., USA Post 2 nd Tx 2.6 Pre-Tx Immediate after Courtesy of J. Rapaport MD., USA Post 1 st Tx 2. eco2 Treatment Protocols Pre-Tx Post 2 nd Tx Courtesy of D.Holcomb MD., USA

22 2. eco2 Treatment Protocols Large Pore & Fine Wrinkles Beam Size ( μm ) Peak Power (W) Mode Pulse Energy (mj) Total Density (spots/cm 2 ) No. of Passes Treatment Interval No. of Sessions Static 10~20 75~200 1 passes 4 weeks eco2 Treatment Protocols III. PATIENT S TREATMENT PROTOCOLS <Treatment Guidelines > * In the Static Mode, 1-2passes with density of 75 or 100 spots/cm 2 are recommended. * For large pores, pulse energy from 10 to 20mJ is appropriate. * For Fine wrinkles, pulse energy need to be adjusted up to 50 mj. * After finishing the treatment in the Static Mode, switch to the Dynamic Mode and treat the borderline with the same Pulse Energy. Pre-Tx Post 1 st Tx Courtesy of W.S.Kim, M.D Korea Courtesy of D.Holcomb MD., USA Pre-Tx Post 1 st Tx Lutronic Corporation All Right Reserved

23 Uneven Skin Tone Beam Size ( μm ) Peak Power (W) Mode Pulse Energy (mj) Total Density (spots/cm 2 ) No. of Passes Treatment Interval No. of Sessions 300 or Static ~200 1 passes 4 weeks 3 < Treatment Guidelines> * In the Static Mode, set the pulse energy from 16-20mJ * 1-2 passes with the density spots/cm 2 are recommended. * In the Static Mode, spots/cm 2 can be added on pigmented areas in addition. * 300 tip is recommeded for superficial pigment ablation. Pre-Tx Post 1 st Tx Courtesy of W.S.Kim, M.D Korea 2.8 III. PATIENT S TREATMENT PROTOCOLS 2. eco2 Treatment Protocols

24 2. eco2 Treatment Protocols Non-facial Areas (Neck, Chest, Hands) Beam Size ( μm ) Peak Power (W) Mode Pulse Energy (mj) Total Density (spots/cm 2 ) No. of Passes Treatment Interval No. of Sessions Static passes 4~6 weeks 3 <Treatment Method> 2.9 * 300 μm tip is recommended for superficial skin ablation. * Aggressive procedures should not be used on non-facial skin because of the substantial risk of potential scarring and hyperpigmentation. * Laser Treatment for the body area should be performed at lower energies, except when treating scars or other indications requiring deeper penetration. 2. eco2 Treatment Protocols Courtesy of M.Rubin, M.D USA Pre-Tx Post 1 st Tx Pre-Tx Post 2 nd Tx Courtesy of D.Holcomb, MD., USA Lutronic Corporation All Right Reserved

25 2.2. Scar Treatment Acne Scar Beam Size ( μm ) Peak Power (W) Mode Pulse Energy (mj) Total Density (spots/cm 2 ) No. of Passes Treatment Interval No. of Sessions Static 50~90 50~100 1~2 passes 4~6 weeks 3~5 < Treatment Guidelines > * In the Static Mode, treat facial scars using 80mJ of energy with a low density of 50 spots/ cm 2. * 1-2 passes with a density of spots/cm 2 are recommended. * After treating in the Static Mode, switch to the Dynamic Mode. Then, adjust the pulse energy down to 20-30mJ and mainly target borderline for a feathering effect. * For most Caucasians, we recommend to treat facial scars using an energy of mJ in the Static Mode. Skin type I or II can be treated with a higher pulse energy and a more aggressive total density of 100 spots/cm 2 with 2 passes. After finishing the treatment in the Static Mode, switch to the Dynamic mode with the energy of 20-30mJ. Treat with a low pulse rate below 100Hz for a full face treatment. * Although a higher energy is used, patients may not experience severe pain during the treatment. * Post operative cooling is recommended for the reduction of prolonged erythema and edema. * Because a scar is a deep lesion, 120um Tip is strongly recommended for a deeper penetration eco2 Treatment Protocols Pre-Tx Post 1 st Tx Post 2 nd Tx Courtesy of K.T.Hong, M.D Korea

26 2. eco2 Treatment Protocols Pre-Tx Post 1 st Tx Courtesy of K.T.Hong, M.D Korea eco2 Treatment Protocols Pre-Tx Post 1 st Tx Courtesy of M.Lee, M.D Korea Pre-Tx Post 1 st Tx Courtesy of K.T.Hong, M.D Korea Lutronic Corporation All Right Reserved

27 Burn Scar Beam Size ( μm ) Peak Power (W) Mode Pulse Energy (mj) Total Density (spots/cm 2 ) No. of Passes Treatment Interval No. of Sessions Static 50~90 50~100 1~2 passes 4~6 weeks 3~5 <Treatment Guidelines> * It is recommended to start to treat burn scars 6 months after the scar has settled. * Treating burn scars with eco2 is similar to the pinhole method using conventional CO2 laser. eco2 can penetrate deeper into the skin with a maximum depth of 2.5mm in a single beam, therefore a thicker scar also can be treated. * According to the thickness and hardness of the scarring, the pulse energy can be selected. * In the Static Mode, treat burn scars using 60-80mJ of energy with low density of 50 spots/cm 2 * 1-2 passes with density of 50 spots/cm 2 are recommended. * Old and hard scar can be treated with a higher total density. * After treating in the Static Mode, switch to the Dynamic Mode. Then, adjust the pulse energy down to 30mJ and mainly target borderline for a feathering effect. * Hard tissues will be softened with multiple micro holes created in the dermis. With new collagen formation, pale burn scars are gradually change to a pinkish color. And the scar areas will turn smaller and softer. For reddish scars, combine treatment with pulsed dye laser method. * For Burn scars, long-term treatments are necessary, and even with various treatments, it is not easy to recover a normal skin structure and function in the burn scar area eco2 Treatment Protocols

28 2. eco2 Treatment Protocols Hypertrophic Scar & Keloid eco2 can assist in flattening the appearance and softening of a dense fibrotic tissue of hypertrophic scars and keloids. Improvements can be noticed after 1 session. Beam Size ( μm ) Peak Power (W) Mode Pulse Energy (mj) Total Density (spots/cm 2 ) No. of Passes Treatment Interval No. of Sessions Static ~ ~ pass 4~6 weeks 3~ < Treatment Guidelines > * Do not exceed a density level of more than 100 spots/cm 2. * Treatment Interval should be a minimum of 4 6 weeks. * For fresh and reddish scars, combine treatment with the pulsed dye laser method in order to control vascularity. 2. eco2 Treatment Protocols <Reference> Keloid Treatment : eco2 therapy with Bleomycin * Generally, Keloid may be worsend by aggressive laser treatment. Therefore, conservative approach is needed. * eco2 can be combined with transdermal drug delivery. eco2 creates micro ablative columns with very fine and thin necrotic wall, drug easily penetrates through MACs. * Treat Keloid with eco2 in the static mode (30mJ, 200 spots/cm 2, 2passes; the lower the pluse energy, the higher the total energy compared with a single eco2 treatment.) then apply bleomycin 1.5 u/ml (Dilute 15mg bleomycin with 10cc of saline) * As you can see from images on the right side, combination use of eco2 and bleomycin results in healing keloid by preventing excessive fibroblast formation and reducing vascularity. (Espana A, Solano T, Quintanilla E. Bleomycin in the treatment of keloids and hypertrophic scars by multiple needle punctures. Dermatol Surg 2001;27(l):23-7) Pre-Tx Post 5 th Tx Pre-Tx Post 1 st Combi-Tx (eco2 +Bleomycin) Courtesy of W.S.Kim M.D., Korea Lutronic Corporation All Right Reserved

29 Atrophic Linear scar Atrophic scars can be effectively resurfaced with eco2. Beam Size ( μm ) Peak Power (W) Pulse Energy (mj) Total Density (spots/cm 2 ) No. of Passes Treatment Interval No. of Sessions ~ ~ 200 2~4 passes 4 weeks 3 < Treatment Guidelines > * In Static Mode, treat atrophic scars using 40mJ of energy. 2-4 passes with density spots/cm 2 are recommended. * Normally, linear scar is narrow and small. Therefore, high density treatment is possible without side effects. When treating large area such as the full face, total density should be less than 200 spots/cm 2. However, linear scar can be treated with a higher density of 400 spots/cm 2. * In order to simulate new skin cells regeneration, apply a regenerating cream containing epidermal growth factors for 3 days in a 3 hr interval until the crust has completely formed. * The proper energy level and the total density are correlated to the depth of the scar and skin type. If too much energy and density are applied, scar irregularity might improve, but transient hyperpigmentation can occur. Take caution for hyperpigmentation in Asians and dark skin patients eco2 Treatment Protocols Pre-Tx Post 1 st Tx Pre-Tx Courtesy of S.I.Chun M.D., Korea Post 3 rd Tx

30 2. eco2 Treatment Protocols Striae Distensae Stretch marks, or striae usually occur as a result of excessive and rapid skin stretching or hormonal changes. Fractional therapy presents a new and effective modality for the improvement of striae. Beam Size ( μm ) Peak Power (W) Mode Pulse Energy (mj) Total Density (spots/cm 2 ) No. of Passes Treatment Interval No. of Sessions Static ~ ~200 1~2 passes 6 weeks 3~ eco2 Treatment Protocols < Treatment Guidelines > * Use the Static Mode and evenly lase the striae region with100 spots/cm 2. Allow sufficient cooling post treatment to calm down the treated zone. Treatment with eco2 takes about 10 minutes depending on the size of the stretch mark. Non-facial skin regeneration process is slower than facial skin. Therefore, body regions necessitate less energy and density when compared to facial regions. Transient hyperpigmentation may arise if parameter settings are above the recommendation. Make note of when the edema and erythema disappears, because this reflects the speed of the skin regenerating process. Proceed unto the next session keeping the appropriate treatment interval. Lutronic Corporation All Right Reserved

31 2.3. Nevus, Syringoma, and Wart Beam Size ( μm ) Peak Power (W) Pulse Energy (mj) Total Density /Pulse Rate No. of Passes Treatment Interval No. of Sessions Remarks ~30 ~ 40Hz N/A 4-6 weeks 1-2 Conventional approach ~ spots/ cm passes 4-6 weeks 1-2 Fractional approach <Treatment Guidelines > * In the Dynamic mode, remove the single lesion separately using a point beam with the S120 tip. (Similar with the ultra pulse mode approach and the conventional CO2 Laser Treatment) * Combination therapy with skin delivery can be also used. * For syringomas that are widely spreaded under the eyes, use a small scan size (e.g. 4*4mm) with a normal 120 tip in the Static Mode. If the scan size is reduced, high density treatment can be adjusted without side effects. Density per each pass can be increased up to 200spots/cm 2 per pass. 1-2 passes are recommended eco2 Treatment Protocols Pre-Tx Post 1 st Tx Pre-Tx Post 1 st Tx Courtesy of W.S.Kim M.D., Korea

32 2. eco2 Treatment Protocols 2.4. Skin Delivery eco2 Treatment Protocols Transdermal drug delivery is delivery of medications to the skin. Transdermal drug delivery method improves patient s response and comfort via non-invasive, painless and simple topical application. It is theoretically ideal for many injected and orally delivered drugs, but most drugs cannot pass through the skin because of normal skin barrier which is called, stratum corneum. Through micro ablative holes made by eco2 treatment, drug transport can be facilitated. When the transdermal drug delivery is combined with eco2 laser system, synergy effect can be expected. eco2 can greatly enhance the permeation of macromolecules through the skin barrier. Combination of transdermal drug delivery method with eco2 leads to excellent results, compared to a single treatment of eco2 or a transdermal drug delivery. Advantages of combination therapy of eco2 with Drug Delivery are as follows: * Effective drug penetration by ablative fractional laser treatment * Easy control of the proper ablation depth of micro holes in order to deliver therapeutic agents through skin tissue * Rapid drug absorption is possible because of the narrow necrotic walls which are created by eco2 (If the thermal damage is too aggressive, drug is difficult to be absorbed through the thick necrosis.) * And additional downtime is not needed due to drug delivery with sharp microbeams (120 microns) compared to MTS method. * Topical application followed by eco2-the two step process is simple. * Synergistic effects can be expected through eco2 treatment routinely combined with drug delivery for the improvement of scar, wrinkle, skin tone and laxity * The dermal collagen remodeling process effects the skin s long term improvement. Lutronic Corporation All Right Reserved

33 eco2 treatment with Botox General Mesobotox treatment for skin rejuvenation requires at least 50 injections in the skin, which is accompanied by pains, and bruises that lasts for a week. Patient-friendly treatments may be acquired by Botox treatments after mild CO2 fractional treatments. Advantage of eco2 is quick recovery, shrinkage of sebaceous glands and blood vessels after botox treatment which reduces facial flushing after one session. Synergistic effects by eco2 treatment with Botox are skin regeneration such as improvement of irregular skin tone, oily skin condition and wrinkle reduction. Improvement of Wrinkles and Skin Tone 1) eco2 : 14mJ, 200spots *2 passes = 400 spots (Low Pulse Energy, High Density) 2) Topical application of Botox : units of botox (reconstituted with 4cc of saline), Apply on the full face (slightly dampen) 3) Post-operation occlusion (put Tegaderm and remove it on the following day) eco2 Treatment Protocols Pre-Tx 2 weeks after Tx 4 weeks after Tx Courtesy of W.S.Kim M.D., Korea

34 2. eco2 Treatment Protocols eco2 treatment with TCA Topical application of TCA has a good peeling effect. Ablation depth is controlled by percentage of TCA. Deeply penetrated TCA induces collagen remodeling in the dermis; however, it also easily induce PIH, scarring and prolonged downtime. When eco2 is combined with a topical application; a low % of TCA, resulted in less down time and achieved a more dramatic effect, compared with a single high % of TCA peeling treatment. Congenital Melanocytic Nevus (CMN) : Operations under local anesthesia is required to treat CMN. : This combination treatment reduces the discomfort for patients. 1) eco2: 30mJ (multiple stacking x2), 300 spots 2) Topical application of TCA : 35% 1 pass eco2 Treatment Protocols Pre-Tx Post Tx Pre-Tx Post Tx Courtesy of W.S.Kim M.D., Korea eco2 treatment with Bleomycin Viral Wart : Cryotherapy is normally used for Viral Warts; however, the results are not satisfactory. It is not easy to remove viral wart with a conventional CO2 laser. 1) eco2 : 40mJ, 600 spots (300 spots *2 passes) 2) Topical application of Bleomycin : 1.5 u/ml (Dilute 15mg bleomycin with 10cc of saline) Pre-Tx Courtesy of W.S.Kim M.D., Korea 2 weeks after 1 st Tx Lutronic Corporation All Right Reserved

35 2.5. Combination Therapy of eco2 and MOSAIC Certain skin conditions (e.g. acne scar and photo aged skin) may be improved more efficiently by utilizing both nonablative and ablative fractional lasers with both 1,550 nm and 10,600 nm wavelengths. Synergistic outcome comes out from the same session or alternate session of a combination treatment with the eco2 and MOSAIC Alternative Combination of MOSAIC and eco2 For an immediate and dramatic effect, eco2 treatment is recommended in the first session of combination therapy program. Treat with eco2 once or twice. And, proceed to additional 2 to 3 sessions of MOSAIC treatment with 4 weeks interval. Session 1: eco2 Static mode : Lower energy, Lower density(e.g mj, density), Single pass Then, blend the borderline in the Dynamic mode Note: Refer to 2.1 skin rejuvenation and 2.2 scars weeks interval is required until the next session with MOSAIC Laser Session 2: MOSAIC Static Mode : High energy (above 70-80mJ), Low density 50 spots/cm passes Then, add treatment in the Dynamic Mode : Lower energy (e.g mJ), Higher density (300 spots/cm 2 ) 1/2 Speed, 1 pass Note: Refer to the specific treatment parameters recommended in MOSAIC HP physician s clinical guide 2. eco2 Treatment Protocols Pre-Tx After eco2 Treatment After MOSAIC Treatment Courtesy of K.T.Hong M.D., Korea Pre-Tx After Combination Tx Pre-Tx After Combination Tx

36 2. eco2 Treatment Protocols Combination therapy in the same session Fractional laser eco2 ablates the skin. Therfore, serum and pin-point bleeding can be occur when a high pulse energy is used in an eco2 treatment. For this reason, non-ablative fractional MOSAIC laser is recommended initially. Then, proceed to ablative fractional eco2 laser therapy. The pulse energy and density should be adjusted lower than a single treatment with MOSAIC or eco2 separately eco2 Treatment Protocols Step 1: MOSAIC (Non-ablative Fractional Laser) Static Mode, High energy (above 70mJ, up to 120 mj*), Low density(50 spots/cm 2 ), 1 pass Step 2: MOSAIC (Non-ablative Fractional Laser) Dynamic Mode, Lower energy(e.g mJ), Adjust the density based on the patient s skin response. Following with eco2 treatment should be also considered. (For Skin types III-V : below 100 spots/cm 2, For Skin types I-II : available up to 300 spots/cm 2 ) Step 3: eco2 (Ablative Fractional Laser) Static Mode, Single pass. Treat for wrinkle or scar area. (For Skin Type III-V, 30-40mJ, 100 density // For Skin Type I-II, 100mJ, 200 density) Step 4: eco2 (Ablative Fractinoal Laser) Dynamic Mode, Blending on the borderlines Pre-Tx 1 month after Combi Tx Courtesy of D.Holcomb M.D.,USA Pre-Tx 1 month after Combi Tx Pre-Tx 1 month after Combi Tx Lutronic Corporation All Right Reserved

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38 3. Pre Operative Care 3.1. Pre-Treatment Guide for eco2 laser therapy Step 1. Consultation Before performing eco2 laser therapy, every doctor should first review the patient s symptoms, clinical history, and health condition and check for any contraindications. Patients should be notified of potential complications and expected outcomes of the therapy Pre Operative Care * Check following questions in order to properly assess if patient is qualified for eco2 laser treatment Has previously received treatment for the condition? Is the patient currently using retinoid or similar medication? Has the patient been taking immunosuppressive medication in the past year? Does the patient have any allergic reactions towards topical lidocaine? Does the patient have a history of cold sores or herpes labial? Does the patient have a history of keloid formation? Is there a history of collagen vascular disease or immunodeficiency? Are there other dermatologic conditions present which could spread after the treatment? Has the patient been tanning recently? Does the patient smoke, use excessive alcohol and or illegal drugs? Does the patient have realistic expectations of the laser teratment? Will the patient comply with all preoperative and postoperative instructions? Step 2. Preparing the Treatment Area of Skin Clean the treatment area thoroughly and remove any make-up and sebum. Take at least three photographs from the sides and of the front view prior to treatment. Step 3. Applying Topical Anesthetic Apply topical anesthetic on the skin surface. Wait for minutes. Nerve block is not necessary for eco2 treatment * In order to prevent drying of the anesthetic ointment and to help the absorption of the anesthetic ointment into skin, film covered dressing must be applied on the treatment area. (Occlusion Effect). * Strictly observe the recommended induction time according to the different anesthetic concentrations to avoid accidental chemical burning to the treatment area * Apply topical anesthetic just a little bit wider than the borderline of the treatment area to minimize the pain that the patient may feel in case the handpiece tip passes over the borderline during the treatment. Step 4. Removal of Topical Anesthetic After minutes, wipe off the topical anesthetic thoroughly. (10600nm wavelength has a high absorption rate to water. If topical anesthetic is not completely removed, it might results in an unsatisfactory clinical outcome.) Lutronic Corporation All Right Reserved

39 3.2. Contraindication & Possible Complications The eco2 laser system is very effective in renewing a patient s skin with various problems such as scars, wrinkles, and photo-aged skin. However, just like any other laser treatments, it may have some negative effects for a few patients Contraindications Skin allergy to local anesthetics, antibiotic medication, and or any other types of medication. Open wound on the treatment area. History of herpes simplex within the past few months. Photo-sensitive skin. Psycho-neurotic patients including alcoholics or drug abusers. Patients who are unable or unwilling to follow the post-treatment instructions. Patients with unrealistic expectations on the clinical outcome of the treatment. Patients with cancer or other malignant diseases. Patients with skin lesions caused by Diabetes Mellitus, Connective Tissue Disorders, Radiation Therapy, and or Chemotherapy Factors which Affect Downtime * Young patient s skin may swell or itch more at downtime (wound healing procedure) * Sensitive skin-rosacea patients may have more swelling. * Erythematous patients may have more pin-point bleeding * Non facial areas will take longer to heal Pre Operative Care Expectations After treatment with the eco2 laser system, in most cases, satisfactory clinical effects are expected even after one session. But the clinical result depends on each individual. Therefore patient should be informed of all relevant information regarding laser treatment so that they are not unrealistically optimistic about the outcome of the therapy.

40 3. Pre Operative Care Possible Side Effects and Care * Prolonged Erythema and Edema daily cooling and moisturizing * Delayed Pinpoint Bleeding : press bleeding point using a clean and dry cotton pad in order to stanch. : avoid moving facial muscles or rub the treated area. * PIH It can be diagnosed 4 weeks after the treatment, VRM Laser toning or bleaching agent can be applied. (Refer to the Spectra VRM physician s clinical guide) * Herpes Simplex Anti-virals (Acyclovir, oral) : prescribe oral anti-viral medication for about 3 days post operation to prevent herpes simplex. * Inflammation NSAIDs(oral), Corticosteroids(topical or I.M.) : To sooth temporary irritation of sensitive skin such as itching, apply 1% hydrocortisone which has anti-inflammatory effect day and night. But, do not apply contiously for three days. * Infection Antibiotics(oral) (In order to avoid acne breakouts and prevent inflammation) Pre Operative Care <Reference > Skin Dimpling Phenomenon For Skin types III-V, temporary skin dimpling phenomenon might be observed. It can be observed in patient who s skin recover late. It can also appear in non-facial regions like the arms and legs. Dimpling phenomenon might appear temporarilly during the process of skin regeneration. It will naturally disappear when the dimpled area recovers from the wound completely. In order to facilitate recovery, treat with non-ablative fractional MOSAIC laser with a 4 week interval. Or, apply a regeneration cream containing growth factors which promotes wound healing. This phenomenon can occur when the patient is treated with ablative fractional laser that radiates beams into the dermis deeper than 1mm. Or a high pulse energy treatment parameters can cause temporary dimpling phenomenon. In treating with eco2 system, a high pulse energy above 100mJ may cause this phenomenon. This phenomenon is not observed at treatment with pulse energy below 60mJ Treating Sensitive Areas * Highly sensitive areas such as the upper lip or periorbital area will require a lower pulse energy and density than non-sensitive facial regions such as the cheek regions. * Non-facial skin regenerates slower than facial skin. Therefore, body regions require lower energy and less density when compared to non-sensitive facial regions. * It is recommended to use the lower range parameter settings for sensitive areas, whereas non-sensitive areas can tolerate the upper range or even slightly exceed the given parameters. * In particular, the perioral area requires special attention as herpes simplex or PIH is likely to occur after laser treatment. * In general, the Total Density of sensitive areas should be around 1/2 of non-sensitive areas. * Always examine the skin s reaction and cool the treated area immediately after each stamp. * If possible, examine the patient s skin reaction over a period of 1-3 days post treatment. Lutronic Corporation All Right Reserved

41 3.4. Cautions for eco2 Operation The treatment parameters for each lesion should be adjusted properly based on the skin s reaction of each patient. When performing the first operation, always use relatively lower Pulse Energy and Total Density. Clinical parameters for followed session can be gradually increased based on the skin s reaction (e.g. erythema and crust peeling-off) and clinical effects in the previous session. * Based on the characteristics of the lesions and skin type, the Pulse Energy should be adjusted properly. * When using scan size 12*12, avoid Density settings more than 100spots/cm 2 in the Static Mode in each pass. * When Total Density reaches higher than 200spots/cm 2, even with a low Pulse Energy, PIH might occur. Therefore, operators should pay special attention. However, a small scan size such as 4*4 can be safely used for a high density treatment * When a high total energy is needed, increase the number of passes. * In general, routine treatment requires 1 or 2 passes at each session. * Even at the same pulse energy(mj), if the peak power setting is low, pulse duration would be longer than at high peak power setting. (Peak power adjustment is available in the eco2 premium model only) * First, treat in static mode over localized skin lesions (e.g. scars, large pores). Next, smooth out the border line with the dynamic mode for a more natural-look (Feathering effect) * In the Dynamic Mode, as Pulse Rate (Hz) gets lower, laser beam radiation is more easily controlled. In general, Pulse Rate of 100 Hz or less is required for a beginner users. * When treating a large area, select the largest scan size, and avoid unnecessary overlapping of previously scanned areas * Sufficient air cooling prior to, during, and post treatment helps reduce post-treatment side effects such as PIH. * When treat high pulse energy, use of hydro-gel such as Bioskin is recommended since it helps to prevent PIH and wound-healing. * The occurrence of PIH is more closely related to total density and the size of the lesion than pulse energy and penetration depth. Small scars can be safely treated with higher density. However, wider areas should be treated with a lower density. CO2 fractional laser treatment for wide areas such as the face or neck, the occurrence rate of PIH would increase. Although indications are the same, wider scars should be treated with a lower density compared to small scars. * Ablative fractional laser vaporizes tissues. This increases the occurrence of PIH since the skin barrier was damaged and more inflammatory cells are produced during the wound healing process. When increasing the Pulse Energy in the Static Mode, do not exceed a Total Density above 200spots/cm 2. However, relatively higher density can be used to treat smaller treatment areas Pre Operative Care

42 4. Post Operative Care 4.1. Skin s Reaction after Operation When treating patients of all skin types and ethnicity, the physician should determine the proper clinical endpoint based on the patient s skin s reaction. In most cases, the endpoint will be determined when the suggested amount of total density has been reached. However, the physician should primarily be concerned with the amount of erythema, edema, and pain involved in each clinical situation. On a case by case basis, the patient s reaction to laser irradiation should be the principal means to end a treatment session Post Operative Care <Incidence of Pain > The eco2 laser system creates micro laser beams that penetrates deep into the dermis. This causes immediate vaporization of tissues, and conducts heat laterally to the surrounding tissues. However, the lateral heat diffusion to the surrounding tissue is significantly minimized because immediate vaporization expels the heat out of the tissues of the treated area. At the same time, nerve endings of the nearby tissues is blocked, thus patient rarely feels pain during the treatment procedure. However, when higher pulse energy is applied, patient might feel unavoidable pain during the treatment. In order to free patient from this pain, topical anesthetic is generally used. The treatment can be painful for those with sensitive skin type. Topical anesthetic and forced air cooling are used to alleviate most of the pain. When treating for superficial indications or skin rejuvenation, the air cooling system should be kept low. When treating deeper indications, higher cooled air settings in combination with higher energy levels may be used. However, there will be patients that will not be able to tolerate the pain. First, adjust the pulse rate to a lower setting. If the patient still cannot tolerate the applied energy level, then reduce the pulse energy level or discontinue the treatment. <Pinpoint Bleeding> Mild pinpoint bleeding occurs immediate after a eco2 treatment. This means micro laser beams have penetrated deep into the dermis. However, this is a natural reaction of the skin, therefore doctors should always explain about this phenomenon prior to the treatment so that patient would not be alarmed by it. Press bleeding point using a clean and dry cotton pad. In most cases, the bleeding will stop by its own coagulation within an hour. No other interventions are needed. <Flushing and Edema> Erythema with some sunburn symptoms will persist for 1 to 3 days post treatment, but this will completely disappear within a week. <Bronzing and Flaking> From the 2nd day after treatment, the skin color will look a little bit darker. This phenomenon is due to the formation of intact epidermal debris that will peel off naturally later on. Although complete peeling varies depending on the skin type of the patient and the location of the skin lesion, generally it takes only 3 to 7 days to peel off completely. Lutronic Corporation All Right Reserved

43 Skin s Response Immediately after Treatment Pre Tx Immediate after Tx Courtesy of M. Lee, M.D Korea Skin Recovery Process Post Operative Care Pre Tx Post 4 days Post 7 days Post 2 weeks Post 3 weeks Post 4 weeks Courtesy of K.T.Hong, M.D Korea

44 4. Post Operative Care 4.2. Post-Treatment Instructions Immediate Post-Op < Post Care for Ablation > * Light antibiotic lotion or a layer of emollient (e.g., Vaseline, Aquaphor ) can be applied to the treated surface to prevent any invasion of bacteria or pathogens, and or regeneration cream can be applied. (e.g.: Avene Cicalfate Cream, La Roche-Posay Cicaplast) * There might be pin-point bleeding on some area. Please press bleeding point using a clean and dry cotton pad in order to stanch. Then, apply emollient or regeneration cream Post Post Operative Care Care < Cooling > * Ice pack or air cooling for 20 to 30 mins (until patient feels comfortable) * If an ice pack is applied, please be sure that the ice pack is enclosed in a sterile and clean dry gauze to prevent direct water contact to the treated area. * Wet Cold Dressing : apply saline soaked gauze on the treated lesions for 20 minutes. (for a cooling and soothing effect) Post Day 1 * Advise patient to avoid contact with water to the treated area on the day of treatment. * Washing is allowed after 24 hours post treatment. * Tell patients that they do not need to do anything pertaining to wound care until the next morning. * Patient may experience a burning sensation for 1-2 hours immediately after the treatment. * Cold compresses or ice packs may reduce swelling and the sunburn sensation * If the patient experiences slight pinpoint bleeding, apply dry gauze compress. * To soothe temporary irritation of sensitive skin such as itching, apply 1% hydrocortisone which has anti-inflammatory effect day and night. But, do not apply continuously for three days. Lutronic Corporation All Right Reserved

45 Post Day 2 to Day 3 * From the second day following treatment, the patient can wash, shower, and apply make-up or shave. * Moisturizing the treated area in the morning and evening helps soothe redness. * The Skin tone of the treated area darkens, showing a rough bronzing appearance. This is a normal sign of the tissue regeneration process. Post Day 4 to Day 7 * In regards to the face, micro crusts will slowly shed within 3-7 days post treatment as the old tissues are replaced. (On Off-face areas, micro crust sheds slower) * Do not forcefully remove the micro crust. * Wash the treated area gently, and do not scrub. * After the micro crusts flakes off within 7 days, the treated skin will have some pinkness and mild swelling. The pinkness will gradually subside. * The regenerated skin is sensitive and must be protected from sunlight; Sun screen should be applied responsibly on the treated area during daytime. Post 1 week to 3 weeks * Avoid using cosmetics containing alcohol for at least for 2 weeks. * Do not be involved in vigorous exercise or go into sauna for at least for 2 weeks. * For approximately 30 days, apply sunscreen lotion with SPF above 30. * Use an umbrella, and wear a cap or any other sun protective wear while outdoors Post Operative Care Follow-up *Treat every 4 weeks, for 3 sessions *After 3 sessions, maintenance treatment should be given every 2 to 3 months. <Notes> Inform the patients that collagen stimulation will continue for up to 6 months after eco2 treatment, therefore, final assessments of wrinkle/scar improvement should be deferred until that amount of time has passed.

46 4. Post Operative Care 4.3. Q & A Q: How long does it take for a full face treatment with eco2? Routine eco2 treatment for the full face only takes minutes per session using combination therapy of the static and dynamic mode. When the skin sensor is ON, time can be further reduced down to 8 minutes if the operator has good treatment skills with a lot of experiences Q: How painful is it during eco2 treatment? Only topical anesthetic such as EMLA is used for routine eco2 treatment. In most cases, patient can endure the pain during treatment with a topical anesthetic. Compared with other laser systems such as non-ablative fractional laser, eco2 causes mild sunburn feeling and less painful since the heat can be expelled out during the vaporization of the tissue Post Operative Care Q: In what instances does pinpoint bleeding occurred during or post eco2 treatment? Is this normal? The occurrence of pinpoint bleeding post treatment is not a side-effect nor an adverse effect. And, pinpoint bleeding is caused by two reasons. First, it indicates sufficient penetration deep into the dermis.. Sometimes there are other CO 2 fractional laser systems which never cause pinpoint bleeding. However, this is only because of insufficient penetration into the skin, meaning the penetration depth was shallow. Insufficient or shallow penetration depth is caused by long pulse duration, lower pulse energy and bigger spot size. These factors easily induce PIH and physician can not get expected results. Secondly, thin necrosis areas are formed after eco2 treatment. Conventional CO 2 laser and other fractional CO 2 laser create thick necrotic area, and thick necrotic wall which is caused by long pulse duration easily induces PIH. However, treatment with eco2 laser induces very thin necrosis. Pinpoint bleeding is just a transient skin reaction which occurs due to the breakdown of blood vessels in dermis. In the eco2 treatment with the pulse energy from 30mJ to 40mJ, necrosis below 40 microns are formed surrounding micro ablative holes. Therefore, normal vessels in the deep dermis can not be blocked by the thin necrotic area. Old patients or patients with thick and oily skin do not usually have pin-point bleeding. Young patients may have more pin-point bleeding with low energy treatment such as 20mJ. These patients have abundant capillary vessels in the dermis. Due to the blood clots and tissue edema after laser treatment, blood vessels of the dermis can be blocked or compressed temporarily. Delayed pin-point bleeding might occur from two hours after or on the next day until the re-epithelialization process is complete. Please press bleeding point using a clean and dry cotton pad in order to stanch. Then, apply vaseline or regeneration cream. Lutronic Corporation All Right Reserved

47 Q: What is the expected downtime after an eco2 treatment? Contrast to Er:Glass non-ablative fractional laser, eco2 shows more distinct micro crusts which occurs after treatment. However, it falls off completely after 5 7 days as erythema and edema calms down. Patient can be involved in their daily activities. And they can put make-up on from the 2nd day after treatment. Shaving is recommended 3 days after the treatment. The downtime is similar with non-ablative fractional laser treatment. Q: What to do for post-treatment of eco2? eco2 is ablative fractional laser which creates vaporization that is an open wound. This open channel can be closed by the process of re-epithelialization within 1 to 2 days. However, preventing infection during the first 24 hours is required. Application of a light anti-bacterial ointment, emollient or regeneration cream right after treatment prevents possible infection. If a patient is allergic to anti-bacterial ointment, hydrocortisone can be used as a substitute to minimize inflammation for the first 2 to 3 days. Application of dressing is not obligatory in all treatment procedure, however, in some cases, it is still recommended to protect the treated skin which promotes the healing process, and minimizes the PIH occurrence. Nowadays, additional protections with hydrogel type dressing such as 2nd skin, bio-skin, Tegaderm are also recommended since these provide both protection and moisturization. Post-treatment cooling is always recommended in all kinds of laser therapy. Use of an air cooler or an ice pack enclosed in a sterile gauze which significantly reduces the occurrence of PIH. Q: Is there a risk of PIH during or post treatment of eco2? eco2 has a very sharp beam size, which significantly minimizes thermal damage to the surrounding tissues, thus, decreasing chances of PIH occurrence. However, ablative fractional laser vaporizes tissues, temporarily exposing skin. This increases the occurrence of PIH since the skin loses its barrier and more inflammatory cells are produced during wound healing process Post Operative Care The occurrence of PIH is more closely related to total density and the size of the treated area than pulse energy and penetration depth. If pulse energy is low and the density is high, PIH might develop. Even when the density is high, the treated area is small such as linear scar, and the occurrence rate of PIH would decrease. < Biopsy of In-Vivo Human Skin, Kangbuk Samsung Hospital > 30W 22mJ microns (D) 30W 160mJ mm (D)

48 5. General Operating Guide 5.1. Parameter Setting Physicians must adjust the pulse energy level and total density according to the indication and skin type. As a general rule, the higher the pulse energy level, the lower the total density. Conversely, lower the pulse energy level, then a higher total density can be achieved. Before starting a new treatment, press the RESET button until 0 is displayed on the Total Energy Counter. All of the treatment indications are given with two sets of parameters; Pulse Energy Level and Density. Within the given range of parameters the user must assess the patient s ethnicity, skin type and sensitivity as these are key factors in determining the appropriate pulse energy level and total density. 5.1 Asian, Indian and dark skins are more prone to post-inflammatory hyperpigmentation(pih) compared to other ethnicities and skin types. With this in mind, a lower range of energy level and total density must be considered. Begin with conservative pulse energy for the first session and gradually increase settings in subsequent treatment session if necessary. If patients are Caucasian, then typically a higher range of energy level can be selected. More aggressive settings can be pursued with a fewer number of treatment sessions, but this approach could result in slightly longer downtime between sessions. 5. General Operating Guide Pulse Energy (mj) The eco2 pulse energy ranges from 2 to 240 mj. The optical micro beam sizes are the same regardless of pulse energy. As the physician raises the energy level, the width and depth of each micro ablative column (MAC) increases. Generally most pigmentation lesions or fresh scars require a low pulse energy setting. Acne scars or skin laxity are treated at high energy levels. But in most of cases (Acne scar, Skin rejuvenation, etc.) physicians can mix the high and low pulse energy during one session for more dramatic clinical results. When adjusting pulse energy, the pulse width automatically changes simultaneously together with Pulse Energy. Density (spots/cm 2 ) & Coverage % Number of radiated spots per one square centimeters. Beam size ( μm ) (tip type) 300um beam size (Tip) is recommended for superficial skin problems. Because compared with the 120um tip, 300um tip s penetration depth is less; a large coverage % at the same parameter can be achieved. Total Energy (kj) During the treatment, eco2 Premium model can display real-time total energy delivered to the patient. This is the total amount of laser-beam radiation and it is the value obtained by multiplying the total number of spots in the laser-beam and its pulse energy. Total Energy( kj) = Accumulated number of radiated spots x Pulse Energy (mj) x 1000 / 1000 Lutronic Corporation All Right Reserved

49 Total Energy Pulse Width Coverage % Regulation of Peak Power 5.2 Adjustment of Peak Power Operation Screen In eco2 Premium Model, peak power can be adjusted from 30 W to 5 W. If the peak power gets lower, the pulse width gets longer at the same pulse energy level. If the pulse width gets longer, the penetration depth gets shallower and necrosis layer gets thicker. In this case, the occurrence rate for pinpoint bleeding gets lowered. For example, indications such as acne scars need deep penetration depth. In this case, use the highest peak power with a short pulse width for deeper penetration of laser beams. For skin rejuvenation, shallow penetration is acceptable with the appropriate thermal effects. Using lower peak power such as 20W, thermal effect on the dermis can be increased. In this condition, collagen remodeling is promoted. APPENDIX - Treatment Procedure 5. General Operating Guide 160mJ 15W 1.4 mm (D), 200 microns (W) 30W 2.5 mm (D), 195 microns (W)

50 5. General Operating Guide 5.2. Operational Mode Setting The Static Mode General Operating Guide Static mode is recommended as the main operating mode in eco2. This mode is very comfortable and easy to treat on a full face compare to the dynamic mode. Normally, patients do not feel discomfort or pain even though a high pulse energy is used in the Static Mode. Choose the proper scan type and size according to the target being treated. There are 7 density levels in the Static Mode. Users can choose from a pulse rate of 25, 50, 100, 150, 200, 300, and 400 spots/cm 2. When treating a large area, select the largest scan size to reduce operation time. In a high density treatment, large scan size is closely related to the occurrence of PIH. For treating periorbital area, small scan size with a high density can be adjusted safely. Clinician should avoid unnecessary overlapping of previously scanned area. Note: In the static mode with 120 tip, avoid density setting higher than 100 spots/cm 2 per pass. If treating with a high total density, repeat the number of passes rather than achieving the same Total Density with a single pass. In general, routine treatment requires 1 or 2 passes at each session. Operation Screen - The Static mode Operation Screen - The Dynamic mode The Dynamic Mode Choosing the Dynamic mode allows the user to smoothen the borderline for a more natural-look with feathering effect. As pulse Rate(Hz) is lowered, laser beam radiation is more easily controlled by the operator. The maximum Pulse Rate varies according to the Pulse Energy. Generally, the recommended Pulse Rate is less than 100Hz. Note: When the Total Density reaches higher than 300spots/cm 2, even with low Pulse Energy, PIH might occur. Therefore, operator must pay special attention. Lutronic Corporation All Right Reserved

51 Skin Sensor eco2 provides the skin sensor option for shorter operation time. * Skin Sensor ON : Recommended for skilled users : The laser will only radiate when the handpiece tip is in contact with the skin and while the foot switch is pressed. : When the skin sensor is ON, skin sensor enabled is displayed on the operation mode screen. But, in case of the s120 tip, as it does not have skin sensor device, the skin sensor does not function. * Skin Sensor OFF : Recommended for eco2 beginner users : The laser will radiate only when the footswitch is pressed in the Ready status. Beam Pattern eco2 laser system provides two kinds of beam pattern. * Random Pattern(Patented Controlled chaos technology) : Lasing Pattern is delivered randomly. A more natural look is expected after the treatment. The distance between spots are spaced apart to reduce the bulk of thermal damage and pain during treatment. * Regular Pattern: Radiates laser having each spot lined up at a regular interval. 5.4 APPENDIX - Treatment Procedure 5. General Operating Guide Operation Screen - Skin Sensor Operation Screen - Beam Pattern

52 5. General Operating Guide 5.3. General Treatment Protocol Step 1. Treatment Parameter Setting First, select operation mode (More commonly used mode is Static Mode). Next, adjust treatment parameters according to each indication General Operating Guide * In eco2 premium model, the peak power can be adjusted from 30W to 5W. * Handpiece tip can be selected: 120, (S120), 300, & the 1000 microns beam size (tips) * Select the pulse energy(mj) and density(spots/cm 2 ) or pulse rate(hz) according to the indication. (Refer to the specific chapters of eco2 treatment protocols) - In the Static Mode, select the Density (less than 200 spots/cm 2 ). - In Dynamic Mode, select the Pulse Rate (less than 100 Hz). Step 2. Operation Technique The tip of the handpiece should remain perpendicular to the skin s surface. * Ensure that the handpiece tip is contacting the skin. Otherwise, defocused beams with shallow depth of penetration will spread on the skin, which will result in unsatisfactory clinical outcome Skin Sensor OFF mode is the commonly used for beginners. If the operator has good treatment skills with a lot of experiences, Skin Sensor ON mode would be more comfortable to save operation time. If the Skin Sensor is OFF, touch the Standby sign in order to turn to Ready. * Next, place the handpiece tip on the skin of the treatment area, then step on the footswitch. Laser beams will not be delivered unless this order is followed. If the Skin Sensor is ON, step on the footswitch first, then place the handpiece tip on the skin. Laser beams will not be delivered unless tip is contacting the skin. * Treat with the Static Mode first for specific lesion area, then apply an additional pass along the borderline with the Dynamic Mode for a more natural clinical outcome. Operator can freely move the handpiece in various motions in the Dynamic mode. * Operator should carefully control moving to the pattern of the handpiece and its speed according to the selected Pulse Rate (Hz). * For detailed information on Maximum Ablation Depth according to different level of Pulse Energy, please refer to the Graph below. Lutronic Corporation All Right Reserved

53 For detailed information on the level of Pulse Energy and Total Energy for each indication, please refer to eco2 treatment protocols recommended in Chapter 2. When treating large treatment area by the Static Mode, select the biggest Scan Type Size(12*12mm). Avoid unnecessary overlapping of previously scanned area. Sufficient air cooling prior to, during, and post treatment helps reduce post-treatment side effects such as PIH. 5.6 Various Handpiece Movements APPENDIX - Treatment Procedure 5. General Operating Guide 10 mj 16mJ 22mJ 26mJ 35mJ 50mJ 60mJ 80mJ 90mJ 110mJ 140mJ 160mJ Pulse Energy and Maximum Ablative Depth at 30W, 120Tip Pulse Energy and Maximum Ablative Width & Necrosis at 30W, 120Tip

54 5. General Operating Guide 5. 4 Additional Operational Options Aiming Beam The aiming beam guides the region being scanned by outlining a scan type so that the operator can visually recognize where the laser will radiate on the skin. Brightness can be adjusted by using the aiming beam control dial on the front of the device. As the dial turns clockwise, the brightness increases, as the dial turns counterclockwise, the brightness decreases. <Notes> Aiming beam of eco2 Premium Model : Red Color Aiming Beam of eco2 Standard Model : Green Color General Operating Guide Memory Button Operation Screen - Aiming Beam This button is for saving treatment parameters frequently used. Nine display settings can be saved in Memory 1,2,3 9 by pressing the button for more than 3 seconds and pressing the YES button on the following pop up window. To recall saved parameters, press the button briefly. Memory Setting Screen (eco2 Premium Model only) Lutronic Corporation All Right Reserved

55 Scan Type & Size Users can select the desired scan type and scan size by touching either the Scan Type menu on the operation screen or by double clicking the scan type button on the hand piece. Available scan type is different as each operation mode as follows: Scan Types in the Static Mode Scan Types in the Dynamic Mode Multiple Shots It is only available in the static mode. Operator can adjust the number of stacking shots to the same micro vaporized hole. For example, in the case of multiple 3x, laser radiation shot is automatically carried out three times. Conventionally, thickened burn scars have been treated by pinhole method using a carbon dioxide laser. Using this function, eco2 can be used to replace the conventional method. Interval Operation Screen - Multishot In Skin Sesor OFF mode, if foot switch is continued stepping, eco2 automatically lazes energy at regular intervals. Below right figure is appeared when touching Multiple on the upper left side. And, eco2 can be set the interval time with arrow on the right side. Interval represents the time gap of laser irradiation. 5.8 APPENDIX - Treatment Procedure 5. General Operating Guide

56 6. Appendix 6.1. Laser Safety Eye Protection The operator should always handle the handpiece in a safe manner to avoid accidental firing. * All objects that reflect light, such as a mirror, should not be allowed in the operating room. Even though the eco2 laser system is built with a number of safety precautions, all medical personnel in the laser room must wear eye protective goggles that is specific to the 10600nm wavelength of the laser system. * If the laser is used for the periorbital area, ocular shields can be placed on the patient s eyes Appendix Protective Eyewear (for the physician) Protective Eyewear (for the patient) Lutronic Corporation All Right Reserved

57 Equipment Safety A laser warning sign should be clearly displayed outside the entrance of the operating room in which the laser is being used. Store the keys in a secured area that is accessible only to trained operators. In an emergency, laser output can be stopped immediately by using the laser emergency stop switch. To restart the device again, turn the emergency switch clockwise to let the button pop out. After that, turn the key switch to turn off the device and turn it on again. Before each treatment procedure, test fire the laser system on black paper to confirm that it is working properly Only the operator should control the foot pedal during a treatment procedure. After each use, the handpiece should be placed back into the hook located on the system s arm. 6.2 Laser Warning Sign APPENDIX - Treatment Procedure 6. Appendix Emergency Stop Switch Hooking the Handpiece

58 6. Appendix Appendix Lutronic Corporation All Right Reserved

59 6.4 APPENDIX - Treatment Procedure 6. Appendix

60 6. Appendix Appendix Lutronic Corporation All Right Reserved

61 6.6 APPENDIX - Treatment Procedure 6. Appendix

62 6. Appendix Patient Name MICRO-FRACTIONAL SKIN RESURFACING PRE-TREATMENT CONSIDERATIONS Appendix eco2 Micro-Fractional Skin Resurfacing quickly and effectively treats acne scars, skin pigment, tone, texture and wrinkles. The procedure uses CO2 laser energy and a computerdriven handpiece to quickly create micro-ablative columns (MAC) of laser light into the soft tissue. The treatment is termed ablative because it creates microscopic wounds to generate new collagen matrix in the skin. Depending on the desired results, the MACs may be more superficial or of greater depth and spaced closer or farther apart. Healing is very rapid since only a small percentage of the skin is treated. Depending on the treatment s depth and the spacing of MACs, the downtime for recovery can be minimal to as short as a weekend. Downtime may be longer, however, for deeper treatments or for certain combination treatments. Routine skin resurfacing is generally completed using topical anesthesia only but nerve blocks and/or oral medications may be necessary for deeper treatments (i.e. for acne scarring and deeper wrinkles.) eco2 Micro-Fractional Skin Resurfacing offers a number of advantages over other ablative fractional laser systems including random beam placement, improved comfort, faster in-motion treatment and the ability to use higher energy for improved results without compromising comfort. Most patients obtain significant improvement with only 1 treatment, but difficult cases may require up to 2 treatments. The procedure is often combined with other equipments and medications to gain maximum improvements. I have read and understand the above Pre-Treatment Considerations Patient Signature Today s Date Lutronic Corporation All Right Reserved

63 Patient Name MICRO-FRACTIONAL SKIN RESURFACING CONSENT FORM I understand that eco2 Ablative Micro Fractional Skin Resurfacing is intended for treatment of wrinkles, acne scars, skin tone and skin texture and that treatment is commonly performed over facial and non-facial areas. The procedure involves creation of micro ablative columns or MAC (columns of laser light that targets only a small percentage of skin) using a CO2 laser with a computerized scanning hand piece. The treatment is termed ablative because it creates microscopic wounds to the surface of the area. This enables the skin to undergo a remodeling and/or healing process with very little likelihood of significant problems such as scarring or permanent discoloration. I understand that complications including scarring or permanent discoloration are possible. Pinpoint bleeding may also occur. Short-term side effects such as reddening, swelling, mild burning sensation or temporary discoloration of the skin are not uncommon. Milia formation, acne flare-up or herpes simplex virus breakouts in the mouth region are also possible. Patients should expect improvements in skin texture, tone, pigment, reduction of wrinkles and improvement of scar. Depending on the depth of the treatment and the spacing of MACs, the downtime for recovery can be minimal to as short as a weekend. Downtime may be longer for deeper treatments or for certain combination treatments. I understand that treatment is contraindicated in patients currently taking anti-coagulants, with an active skin infection, isotretinoin use in the past year (i.e. Accutane), compromised immune system, history of keloids, pregnancy and with skin cancer in the treatment area. With this in mind, I am choosing to undergo 6.8 APPENDIX - Treatment Procedure 6. Appendix Full-Face Facial Region Neck Upper Chest Hands Other I have read and understand this form and my questions have been addressed and answered to my satisfaction. I have read pre-treatment considerations and post-treatment instructions and I will follow the recommendations outlined to protect my skin. Patient Signature Date of Treatment Witness Signature

64 6. Appendix MICRO-FRACTIONAL SKIN RESURFACING POST TREATMENT CONSIDERATIONS Initial skin care immediately following your eco2 Micro-Fractional Skin Resurfacing treatment includes keeping all treated areas away from contact with water. Do not wash your face until the next morning. Wash and dry your face very lightly by patting it with a moist towel. Be careful not to scrub or use abrasive soap over the next 5-7 days Appendix Keep the treated area covered with petroleum jelly over the next 4-5 days. It is important to avoid drying of the skin, so keep the treated area hydrated. The skin heals faster in a moist environment and drying leads to the formation of crusts. If a thin crust forms, do not pick at it and keep your skin covered with a moisturizer. Viral herpes breakout may occur in the mouth area with laser skin resurfacing. If any blistering occurs, notify your physician or the staff for special treatment instructions for the affected area. Mineral cosmetics are generally tolerated quite well after the initial healing is complete. A sun block of SPF 30+ is recommended to use from the second day after treatment. Direct sun exposure to the treated area(s) should always be avoided for the first week after treatment. Subsequent sun exposure should not be excessive and appropriate sun precautions should be followed. I have read and understand the above Post-Treatment Considerations. Patient Signature Today s Date Lutronic Corporation All Right Reserved

65 Patient DATE Skin Type Chart # STATIC DYNAMIC Total Dentsity 6.10 APPENDIX - Treatment Procedure 6. Appendix Pulse Rate (Hz) Energy Level (2-240mJ) Peak Power (W) Treatment Region FH PORB EYELID NOSE L CHK Total Energy (mj) # of passes Density (spots/ cm 2 ) Energy Level (2-240mJ) Peak Power (W) Total Energy (mj) Tip Size Anesthetic/Meds : Approval : R CHK PORL CHIN NECK HANDS OTHER

66 6. Appendix Indications Beam size ( μm ) (Tip Type) Peak Power (W) Pulse Energy (mj) Total Density (spots/ cm 2 ) Remarks Skin Laxity (Deep Wrinkles) 120 or ~30 50~100 Do 1 pass with 50% an overlapping with a density of 50 spots/cm 2 in the Static mode, then finish the borderline with a pulse energy of 30mJ in the Daynamic mode Skin Rejuvenation Large Pore ~20 75~200 Fine Wrinkles (Periorbital, Perioral) ~20 75~200 Do 1 pass with an overlapping with a density of 75~100 spots/ cm 2 in the Static mode, then finish the bordeline with a pulse energy of 10mJ in the Dynamic mode. Reduce the can size to 4~8mm when treating the periorbital area. 6. Appendix Uneven Skin Tone (Pigments, Telangiectasia) Off-face (Neck, Chest, Hand) 300 or ~ Do 1 pass with 50% an overlapping with a density of 75~100 spots/ cm 2 in the Staitic mode, then finish the borderline in the Dynamic mode. Do 1 pass with a density of 100 spots/cm 2 (without overlapping) in the Static mode, then finish the borderline in the Dynamic mode. < Treatment Tips > * As the peak power is lower and beam size is larger, the penetration depth at same pulse energy is shallower. * Based on the characteristics of the lesions and skin type, the Pulse Energy should be adjusted properly. * When using scan size 12*12mm, avoid density setting more than 100spots/cm 2 in Static Mode in each pass. * When Total Density reaches higher than 200spots/cm 2, PIH might occur even with low Pulse Energy. Therefore, operator should pay special attention. * However, small scan size such as 4*4 can be safely used for high density treatment * When a high total energy is needed, increase the number of passes. * In general, routine treatment requires 1 or 2 passes at each session. * Even at the same pulse energy (mj), if the peak power setting is low, the pulse duration would be longer than at a high peak power setting. Lutronic Corporation All Right Reserved

67 Indications Beam size ( μm ) (Tip Type) Peak Power (W) Pulse Energy (mj) Total Density (spots/cm 2 ) Remarks Acne Scar Burn Scar ~90 50~90 50~100 50~100 Do 1~2 passes with a density of 50 spots/cm 2 in the Static mode, then finish the borderline in the Dynamic mode. Scar Hypertrophic Scar (or Keloid) ~30 100~200 Do 1 pass with a density of 50~100 spots/cm 2 in the Static mode. Atrophic Linear Scar Striae Distensae Nevus, Syringoma & Wart < Treatment Tips > ~30 100~ ~30 100~ ~30 20~40Hz Treat 1~2 passes with a density of 50~100 spots/cm 2 in the Static mode on atrophic linear scar (50% overlapping). Do 1~2 passes with a density of 50~100 spots/cm 2 in the Static mode (caution PIH) Use point beam in the Dynamic mode APPENDIX - Treatment Procedure 6. Appendix *In the Dynamic Mode, as Pulse Rate (Hz) gets lower, laser beam radiation is more easily controlled. In general, Pulse Rate of 100 Hz or less is required for the beginner user (s). *First, treat in the static mode over localized skin lesions (e.g. scars, large pores). Next, smooth out the borderline with the dynamic mode for a more natural- look (Feathering effect) * When treating large areas, select the largest scan size. Avoid unnecessary overlapping of previously scanned area. * When treating with a high pulse energy, use of hydro-gel such as Bioskin is recommended since it helps to prevent PIH and in wound-healing.

68 Skin Laxity Rhytide / Wrinkle Redution Scars / Micro Fractional Resurfacing Lutronic Corporation : 701 Gwanridong Ilsan Technotown , Baeksok-dong, Ilsandong-gu, Goyang-si, Gyeonggi, Korea TEL : FAX : edu@lutronic.com / rev 2.1 Lutronic, Inc. USA : 51 Everett Drive, Unit A-50, Princeton Junction, NJ 08550, USA TEL: / FAX : office@lutronicusa.com Europe Office : 122 Gillott Road, Edgbaston Birmingham B16 OEX U.K TEL : FAX : Lutronic Japan Co., Ltd. : 9F Hakataekimae Center Bldg, Hakataekimae, Hakata-ku, Fukuoka city, Fukuoka-pref., Japan TEL : FAX : China Office : Suite 22, Hyundai Motor Tower, 38 Xiaoyun Road, Chaoyang District, Beijing, China TEL : FAX :