Healthcare Industry News:  fractional skin resurfacing 

Devices Dermatology FDA

 News Release - December 4, 2007

Reliant Technologies Receives Industry's Only FDA 510(K) Clearance for a Fractional Ablative Resurfacing Device

Fraxel re:pair(TM) Laser System Now FDA 510(K) Cleared to Treat Wrinkles, Rhytides, Furrows, Fine Lines, Textural Irregularities, Pigmented Lesions and Vascular Dyschromia

MOUNTAIN VIEW, Calif.--(HSMN NewsFeed)--Reliant Technologies, Inc., the pioneer of fractional skin resurfacing and market leader in aesthetic medicine, today announced that its Fraxel re:pair laser system has received the industry’s only FDA 510(K) clearance for a fractional ablative laser system for treatment of wrinkles, rhytides, furrows, fine lines, textural irregularities, pigmented lesions and vascular dyschromia. The Fraxel re:pair system, initially cleared for ablation, coagulation and skin resurfacing in May, 2007, becomes the only fractional ablative resurfacing system cleared by the FDA for specific indications of use.

The Fraxel re:pair laser is the industry’s only minimally invasive, ablative fractional laser system that delivers a full spectrum of aesthetic treatment from Fractional MicroDermAblation™ (FMDA™) treatment to Fractional Deep Dermal Ablation™ (FDDA™) treatment. It is the only ablative resurfacing device capable of being operated by a single clinician, because of its built-in smoke evacuation system, and capable of treating at depths from 300 micrometers (µm) to 1.6 mm into the dermis, all in a single hand piece.

“In my 20 years of using lasers, I have not seen an ablative technology safely capable of targeting all of the elements of severe photodamage on and off the face, including the delicate neck and chest regions. It is now possible with the Fraxel re:pair system,” said A. Jay Burns, MD, assistant professor of plastic surgery at the University of Texas Southwestern Medical Center and past president of the American Society of Laser Medicine and Surgery.

The Fraxel re:pair laser delivers FMDA treatments for superficial photodamage, including pigmentation, fine lines, texture and vascular dyschromia. It also has the flexibility to deliver FDDA treatment for more severe rhytids and furrows by stimulating new collagen and elastin production deep into the dermis. Treatment is delivered with the safety and proven efficacy of a Fraxel brand treatment.

“The results we are achieving with the Fraxel re:pair system are remarkable by any standard. Results approach that of a facelift, with very few complications and limited downtime,” said Christopher Zachary, FRCP, chair of the Department of Dermatology, University of California at Irvine. “The Fraxel re:pair system produces significant tissue tightening, wrinkle reduction and textural improvement, both on and off the face.”

The Fraxel re:pair laser removes and eliminates aged and damaged skin without the prolonged downtime and adverse reactions associated with traditional bulk ablative resurfacing lasers (also known as bulk CO2 or bulk erbium YAG lasers). Its advanced optics can deliver thousands of microscopic treatment zones up to 2.5 times faster than any other ablative fractional device, generating greater revenue opportunities for practices. It is also the only system clinically demonstrated to create zones of treatment beyond 1.5 mm that are spaced evenly across the skin’s surface. In one treatment session, the Fraxel re:pair treatment removes up to 6 grams of dermal tissue, resulting in thorough tissue tightening, a uniform appearance and effective resurfacing.

“The Fraxel re:pair laser system is the most technologically advanced tool available for a physician today. Reliant’s rigorous scientific development of the Fraxel re:pair laser is backed by data from more than 400 treatments conducted at 10 top clinical centers nationwide,” said Anja Krammer, vice president of marketing for Reliant Technologies. “Unlike other devices on the market, only the Fraxel re:pair system uses state-of-the-art technology that integrates the proprietary Fraxel Intelligent Optical Tracking® system with a CO2 laser source. With just one hand piece, physicians can now effectively treat a broad range of conditions.”

About the Fraxel Systems

The Fraxel® family of products, which includes the Fraxel re:store™ laser system, the Fraxel re:pair™ laser system and the Fraxel re:fine™ laser system, has quickly become the industry standard for fractional aesthetic skin treatment. Unlike traditional laser devices, Fraxel brand fractional laser systems treat only a fraction of skin at a time, leaving the surrounding area intact for fast healing. Fraxel lasers have received multiple FDA clearances and have been found safe and effective in treating many areas of the face and body. The versatility of the product line ensures that patients can choose the best treatment for various stages of their lives as their skin care needs evolve.

The Fraxel re:pair laser is the breakthrough device in ablative fractional resurfacing, with the most clinical testing of any product in the category. Fraxel re:pair treatment has been clinically proven to improve wrinkles, rhytides, furrows, fine lines, textural irregularities, pigmented lesions and vascular dyschromia in a multi-site, multi-phase study of more than 400 patients.

The Fraxel re:store laser, delivering Non-ablative Fractional Resurfacing (NFRTM) treatment, was introduced in 2004 and has been adopted by more than 1,500 dermatologists, plastic surgeons and aesthetic physicians worldwide. It is the accepted gold standard for treating acne scars and periorbital wrinkles, and for skin resurfacing procedures on the face, neck, chest and hands.

The Fraxel re:fine laser, offering superficial non-invasive skin rejuvenation, combines the unique method of fractional delivery with a lighter treatment. Performed in 20-25 minutes, Fraxel re:fine treatment is excellent for medical spas and family physicians seeking a safe and gentle option.

About Reliant Technologies

Reliant Technologies develops clinical solutions to rejuvenate aging and environmentally damaged skin. Reliant is dedicated to providing the most ergonomic and effective products to the global aesthetic marketplace. The company pioneered the development of fractional laser resurfacing that relies on novel high-speed scanning systems and the Intelligent Optical Tracking® system to produce safe and effective results with minimal recovery time. Reliant is based in Mountain View, Calif. For more information, visit www.fraxel.com.


Source: Reliant Technologies

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