FDA grants first 510(k) clearance to Reliant for fractional ablative resurfacing device
January 9, 2008, Mountain View, CA--Reliant Technologies' Fraxel re:pair erbium fiber laser system has received the first 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.
January 9, 2008, Mountain View, CA--Reliant Technologies' Fraxel re:pair erbium fiber laser system has received the first 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. Initially cleared for ablation, coagulation, and skin resurfacing in May, 2007, the Fraxel re:repair system becomes the only fractional ablative resurfacing system cleared by the FDA for specific indications of use.
According to the company, the Fraxel re:pair laser is the 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 also 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 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."