Healthcare Industry News:  fractional skin resurfacing 

Devices Dermatology Regulatory

 News Release - April 10, 2008

Reliant Technologies Announces World Premiere of Fraxel re:pair(TM) Laser: A New Class of Treatment Therapy for CO2 Laser Skin Resurfacing in the EMEA

Fraxel re:pair(TM) system receives CE Mark for European market to treat severe sun damage, sagging skin, wrinkles

PARIS, April 10 (HSMN NewsFeed) -- Reliant Technologies, Inc., the pioneer of fractional resurfacing and market leader of aesthetic laser skin treatments, today announced its European launch of the Fraxel re:pair laser system with this month's CE Mark (Conformite Europeenne) approval. The European debut of the Fraxel re:pair system will take place at the Anti-Aging Medicine World Congress on April 10 - 12 in Paris, France.

The Fraxel re:pair system is now available to dermatologists and plastic surgeons in the European Union, as well as Africa, the Middle East, Australia and Hong Kong. In December 2007, the Fraxel re:pair system 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 industry's only minimally invasive, ablative fractional laser system, the Fraxel re:pair laser delivers a full spectrum of aesthetic treatment from Fractional MicroDermAblation(TM) (FMDA(TM)) treatment to Fractional Deep Dermal Ablation(TM) (FDDA(TM)) 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 to 1.6 mm into the dermis, all in a single hand piece.

"Ablative fractional skin resurfacing with the Fraxel re:pair laser is the biggest breakthrough for wrinkle removal in the last 10 years," said Christopher Zachary, FRCP, chair of the Department of Dermatology, University of California at Irvine. "Results approach those we can achieve with a facelift, with very few complications and limited downtime. 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 system, the result of two years of clinical research, represents a new category in skin rejuvenation: Ablative Fractional Resurfacing (AFRTM) treatment. 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 rhytides 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.

Highlights of the more than two-year multi-site clinical study will be presented at the Anti-Aging Medicine World Congress during the following clinical symposium and live Fraxel re:pair treatment:

-- "A breakthrough aesthetic solution with 3 years of clinical results and patient follow-up," by Christopher Zachary, FRCP, chair of the Department of Dermatology, University of California at Irvine, on Friday, April 11, 2008 at 6:30 p.m. at the Meridien Etoile Hotel (Longchamp Meeting Room 81 Boulevard Gouvion Saint-Cyr)

"The Fraxel re:pair laser, the latest addition to the Fraxel family of laser systems, continues the Reliant tradition of offering patients choices when considering non-invasive treatment options to safely and effectively eliminate skin damage caused by age or the environment," said Anja Krammer, vice president of marketing for Reliant Technologies. "Whatever skin concerns patients may have, Reliant offers a treatment that fits their lifestyle without the common side effects associated with surgical procedures."

About the Fraxel Systems

The Fraxel® family of products, which includes the Fraxel re:pair(TM), Fraxel re:store(TM) and Fraxel re:fine(TM) laser systems, has quickly become the industry standard for fractional aesthetic skin treatment. Unlike laser devices of the past, Fraxel brand laser systems treat microscopic volumes of skin with each unique pulse, 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 that provides Ablative Fractional Resurfacing (AFRTM) treatment, with more clinical research than any product in the fractional ablative 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-year study.

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 http://www.fraxel.com.


Source: Reliant Technologies

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