Reliant wins FDA 510(K) clearance of new handpieces for skin resurfacing, surgery
OCTOBER 10, 2008 -- Reliant Technologies (Mountain View, CA), the pioneer of fractional resurfacing and market leader of aesthetic laser skin treatments, says it has received FDA 510(k) clearance for three new Fraxel re:pair laser handpieces. The handpieces expand the capabilities of the Fraxel re:pair laser system, providing physicians with "a complete skin resurfacing and surgical treatment option."
OCTOBER 10, 2008 -- Reliant Technologies Inc. (Mountain View, CA), the pioneer of fractional laser resurfacing and market leader of laser-based aesthetic dermatology treatments, says it has received FDA 510(k) clearance for three new Fraxel re:pair handpieces. The new tools 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 of the new surgery tools can be used either alone or in combination with each other, without turning the system off to change handpieces.
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, Reliant announced that it has agreed to join forces with Thermage, Inc. (NASDAQ:THRM) in a merger expected to close in the fourth quarter of 2008.