Reliant Technologies Announces FDA 510(K) Clearance Of New Handpieces For Skin Resurfacing And Surgical Applications

Main Category: Dermatology
Also Included In: Medical Devices / Diagnostics;  Regulatory Affairs / Drug Approvals
Article Date: 08 Oct 2008 - 0:00 PDT

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Reliant Technologies, Inc., the pioneer of fractional resurfacing and market leader of aesthetic laser skin treatments, announced that it has received FDA 510(k) clearance for three new Fraxel re:pair laser handpieces. These handpieces expand the capabilities of the Fraxel re:pair laser system, providing physicians with a complete skin resurfacing and surgical treatment option. As part of the Fraxel re:pair Complete Fractional Ablative Workstation, all three surgical handpieces can be used either alone or in combination with each other, without turning the system off to change handpieces.

"The Fraxel re:pair laser system allows me to deliver a comprehensive cosmetic treatment, combining the most advanced ablative fractional resurfacing technology with surgical capabilities," said Howard Conn, M.D., ocular & general plastic surgeon and fellow the American Society of Ophthalmic Plastic and Reconstructive Surgery. "These new handpieces allow me to provide my patients a one-stop treatment option for superior tightening of the skin, lifting of the upper eyelids and improvement of lines on the lower eyelids."

For skin resurfacing, the new Fraxel re:pair 600 micron handpiece performs superficial procedures both on and off-the face, including the neck, hands and chest, and treats fine lines, age spots and sun spots. The 600 micron handpiece can treat up to four times faster than any other ablative fractional device and provides a more uniform treatment with better results and faster healing for patients.

"The Fraxel re:pair laser's 600 micron handpiece is a significant advancement for my practice," said David H. McDaniel, MD, dermatologist and Assistant Professor of Clinical Dermatology and Plastic Surgery at Eastern Virginia Medical School. "Treatment is comparable to a series of IPL treatments plus a series of microdermabrasion sessions, with the added benefit of increased long-term collagen production. This is all accomplished in a single, simple and safe procedure."

The two surgical handpieces include an incisional and ablative handpiece. The 0.2mm Incisional Handpiece provides a safe, effective and reliable alternative to traditional surgical procedures, enabling physicians to perform laser blepharoplasty, also known as eyelid lifts, vermillionectomy of the lip and excisional procedures such as keloid scar and wart removal. The 2mm Ablative Handpiece can safely remove larger sections of soft tissue, enabling physicians to effectively treat a variety of dermatological conditions, including removal of warts, keloids, seborrheic keratoses and actinic keratoses. The Fraxel re:pair 0.2mm Incisional Handpiece and 2mm Ablative Handpiece enable precise tissue cutting with minimal damage, resulting in minimal-to-no bleeding and reduced post-operative swelling and bruising, providing patients with a faster healing and recovery time.

"The Fraxel family of lasers offers the most advanced laser treatments in the market today, providing safe, precise and effective treatments for a range of skin conditions and skin types," said Len DeBenedictis, chief technology officer of Reliant Technologies. "The addition of the new handpieces for the Fraxel re:pair system furthers our market leading position and will allow physicians to provide superior ablative skin resurfacing with the option of performing minor surgical treatments as well."

Recently, it was announced that Reliant has agreed to join forces with Thermage, Inc. (Nasdaq: THRM) in a merger expected to close in the 4th quarter 2008.

About the Fraxel Systems

The Fraxel(R) family of products, which includes the Fraxel re:pair(R), 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 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(R) 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.

Reliant Technologies, Inc.
http://www.fraxel.com