Reliant® Technologies Announces FDA Clearance Of Fraxel Laser For Skin Resurfacing
New Fractional Science Offers "Protected" Approach To Restore Aging and Sun-Damaged Skin
Palo Alto, Calif - March 30, 2005. In the eternal pursuit of younger-looking skin, patients have had to rely on abrasive procedures fraught with long recoveries and the risk of side effects to achieve noticeable cosmetic improvement. Now, Reliant Technologies, Inc., announces that the U.S. Food and Drug Administration (FDA) has granted 510(k) market approval of the Fraxel? laser for skin resurfacing procedures, providing physicians a gentle and intelligent treatment approach to fast, remarkable results with minimal downtime and maximum safety.
Fraxel Laser Treatment (FLT) is the latest beauty breakthrough to restore aging and sun-damaged skin - pixel by pixel, spot by spot. It is the only laser device specially designed to resurface a fraction of skin at a time without breaking the skin's protective outer barrier. Best of all, FLT offers immediate results—softer, smoother and toned skin, with cumulative improvement that creates a healthy, vibrant and youthful appearance in as few as four to eight weeks.
"We are pleased to announce the FDA's clearance of the Fraxel laser for skin resurfacing because it provides our physicians and their patients an innovative and efficacious treatment without the inconvenience of traditional ablative techniques," said Dennis Condon, Executive Vice President, Reliant Technologies. "This regulatory milestone caps off our successful introduction of a new science of fractional resurfacing and is another example of our corporate mission to fulfill the promise of laser aesthetics. We believe the patented Fraxel laser represents the first major invention in laser technology of the 21st century and will be a significant enhancement to physicians' cosmetic treatment regimen."
The latest 510(k) FDA clearance for skin resurfacing was based on a review of clinical performance data comparing Fraxel laser outcomes with traditional ablative CO2 lasers as the predicate device. This new indication for the Fraxel laser joins clearances obtained in 2003 for soft tissue coagulation and in 2004 for correction of periorbital wrinkles and pigmented lesions, including age spots, sun spots and skin discoloration.
Similar to the technique of editing a digital photograph comprised of pixels, Fraxel Laser Treatment precisely produces thousands of tiny columns of treatment zones invisible to the naked eye that target flawed skin and leave surrounding healthy skin untouched. This fractional resurfacing affects between 12 and 20 percent of the skin at any one time, permitting the spared tissue to assist in the rapid healing of damaged cells. FLT also reaches deep into the dermis to stimulate collagen remodeling in the skin layers below. Patients typically require an average of three to five treatment sessions over about four to eight weeks to obtain maximum benefit.
"Our patients have been thrilled with the results from Fraxel laser treatment. The procedure is well tolerated and most of our patients return to their normal activities the next day. The clinical success and patient satisfaction we've seen in a relatively short period of time is remarkable," said renowned laser expert Roy G. Geronemus, MD, Director of the Laser & Skin Surgery Center of New York City. "As we continue to explore the versatility and functionality of this laser technology, I expect we will find more therapeutic and cosmetic applications for fractional resurfacing procedures."
The latest advances with FLT will be featured at the upcoming 25th annual meeting of the American Society for Laser Medicine and Surgery in Orlando, FL, on March 31 - April 3, 2005. Pioneers in the fields of cosmetic dermatology and plastic surgery will present new studies demonstrating the clinical benefits of this sophisticated device.
About Reliant Technologies, Inc.
Reliant Technologies is positioned for growth and poised to become a new market leader in aesthetic laser medicine, surgery and biomedical technologies. Reliant is dedicated to fulfilling the promise of laser medicine by creating breakthrough systems focused on Fraxel Laser Treatment. Reliant employs more than 70 dedicated people and is headquartered in Palo Alto, California.