R avishing. by E vis. FDA Cleared Class II Medical Device for the treatment of mild to moderate Acne
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1 R avishing by E vis FDA Cleared Class II Medical Device for the treatment of mild to moderate Acne Bl u e L i g h t T herapy L E D A c n e Tr e a t m e n t D e v i c e
2 Control Panel Lens Cover AC/DC Adaptor Power Button Connection Socket Ravishing by Evis Blue Light Therapy has been tested to international standards to ensure that its outputs are safe for the eyes. However for your own comfort you may choose to wear patient goggles. 3
3 Blue Light Kills Acne Bacteria Light gets at the core of what causes acne eruptions: P. acnes, the bacterial responsible for causing acne inflammation, pumps out tiny molecules called porphyrins. When those porphyrin are exposed to certain wavelengths of light, they produce free radicals that kill the bacteria. Without P. acnes around to cause inflammation, acne clears up. How It Works The blemish appears. This plug, traps oil and bacteria inside your pore. As your skin continues to produce oil, the pore swells because of the plug, and bacteria flourish. Your pore becomes infected and possibly inflamed. The LED light targets and destroys the bacteria. Normal Pore Clogged Pore Light Destroys Bacteria Acne Classification Acne is classified as being in one of four grades. Each grade builds upon the next with the level of activity in the skin. Grade 1 acne is what is considered a minor breakout. There are a few blemishes, (less then 20 ) blackheads or whiteheads. Grade 2 acne is when there are more blemishes visible. There may be both open/lacerated and closed pimples, (15 to 20), but there is no inflammation. Grade 3 acne is the stage where inflammation is now involved, (20 to 30 blemishes) and the skin will appear reddish in color. Grade 4 is the final stage of acne, sometimes being called Cystic Acne. Grade 4 acne has many blemishes, the skin is red and inflamed and there are cysts which are deeper. Always consult your dermatologist for classification of acne. 5
4 Things to Know About the Ravishing by Evis Blue Light Therapy Acne Treatment 1. Blue light is an acne treatment, not a cure. 2. Blue light is effective against the P. acnes, the bacteria that causes inflammatory acne, or acne vulgaris. Before After Ravishing by Evis Blue Light Therapy is a hand held device that employs light therapy technology: a non-invasive, low-level, non-thermal light energy that addresses one of the suggested underlying causes of acne. The Ravishing by Evis Blue Light Therapy device uses a specific light wavelength that has been proven to be effective in eliminating the P. acne bacteria. Disclaimer Medical Related Information The information provided is not intended to diagnose, treat, cure or prevent any disease. That is between you and your physician. If you have (or think you have) a medical condition, please contact your primary health care provider immediately. 6
5 FAQs Is the Light Therapy process abrasive or painful? How does it feel? Absolutely not. A Light Therapy treatment is a gentle, painless, safe, no heat, non-invasive and non-abrasive treatment. What areas can be treated? Blue light treatments can be used on any part of the body. Face, neck, back and chest. Do I need to cover my eyes during treatment? Ravishing by Evis Blue Light Therapy has been tested to international standards to ensure that its outputs are safe for the eyes. However for your own comfort you may choose to wear patient goggles. Is Blue light a cure for acne? Ravishing by Evis Blue Light Therapy is an FDA cleared medical device that has been proven to treat acne effectively. The wave length that Ravishing by Evis Blue Light Therapy uses eradicates the P. Acne bacteria that causes inflammatory acne or Acne Vulgaris. With consistent treatment you will enjoy a clear, flawless, radiant skin. How long should we expect the device to last? Ravishing by Evis Blue Light Therapy is designed with the highest quality manufacturing standards. We use high quality and powerful LEDs. The LEDs should never need to be replaced. 7
6 Indications for Use Ravishing by Evis Blue Light Therapy is intended for the treatment of mild to moderate inflammatory Acne Vulgaris for use at home. Treatment Protocol We recommend 3 minutes per target area, per treatment 2 times a week for 4-8 weeks. The device will beep every 3 minutes to help time the treatment and will automatically shut off after 6 minutes and may immediately be switched on to continue treatment if desired. After the initial 8 weeks of treatment, maintain results with 2-4 treatments a month as needed. Step by Step Directions for Use Before Treatment Cleanse the skin to remove make up and dirt. Pat the skin dry. Treatment Connect the power cord to the bottom of the device and plug the power adapter into the wall socket. Press the power button once, you will hear a beep. The device is now ready for treatment. Cover the eyes with goggles or moistened eye pads if sensitive to light. (Optional.) Gently place the light directly in contact with the skin over the area to be treated. Hold in place for 3 minutes. You will hear a second beep to let you know to move to another area. After 6 minutes the device will sound 2 beeps and automatically shut off. (To shut off device manually, press the power button.) You may immediately turn device on to continue as needed. Continue this process until you have treated all target areas. When all areas have been treated, if the light is still on press the power button once to shut off the device. After Treatment You may apply a hydrating cream, followed by sunscreen as needed. Wipe the light panel with an alcohol wipe after each treatment. Do not run the device under water. 8
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8 Proudly Distributed in New Zealand by: 651 Rosebank Road, Avondale, Auckland FP: P: E: W:
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