Solta Medical's Fraxel re:store Dual system for actinic keratosis receives FDA 510(k) clearance

Solta Medical, Inc. (Nasdaq: SLTM), the pioneer in fractional resurfacing and non-invasive skin tightening and a market leader in aesthetic skin treatments, today announced it has received FDA 510(k) clearance of its Fraxel re:store®Dual for the treatment of actinic keratosis (AKs). The Fraxel re:store Dual system takes the industry leading fractional laser technology to the next level by adding a novel 1927 nm wavelength, the first ever application of a Thulium laser in the aesthetics market.  The Fraxel re:store Dual treatment provides superior results for the removal of AKs – a common precancerous skin condition caused by sun exposure on the face or other areas of the body.

During a six month clinical study of 21 subjects at several dermatology centers around the country, there was an 83.5% average reduction of AK lesions using the Fraxel re:store Dual's 1927 nm wavelength. Treatments were shown to be effective both on and off the face, including the arms, hands and chest area.  Each subject underwent a series of two to four treatments with the Fraxel re:store Dual that were spaced two to four weeks apart. No adverse reactions occurred for any of the subjects. In addition, the study found improvement in skin texture and pigmentation following a Fraxel treatment.  

"In our study, we found the Fraxel re:store Dual to be the most effective treatment of multiple facial AKs, as it is safe and requires minimal downtime while simultaneously improving other signs of photodamage," said Roy G. Geronemus, MD, Director of the Laser & Skin Surgery Center of New York. "While the 83.5% removal rate was comparable to other topical therapies and AK treatment options, Fraxel was overwhelmingly well-tolerated by all the patients and offers the added benefit of improving a patients' overall skin quality, color and texture."

"By using the Fraxel Dual's 1927 nm wavelength, we were able to see dramatic clinical clearing of facial AKs in our patients after a series of treatments," said Suzanne L. Kilmer, MD, Founder of the Laser & Skin Surgery Center of Northern California. "My patients will now have an effective and safe treatment option for the removal of precancerous lesions on their face as well as on the body."  

"Solta Medical continues to develop safe, innovative anti-aging solutions that deliver the best possible results in non-invasive aesthetic treatments," said Stephen J. Fanning, Chairman of the Board, President and CEO of Solta Medical, Inc.  "With the FDA clearance of our Fraxel re:store Dual system, we are providing our physicians with cutting-edge technology that patients are seeking, specifically in terms of reversing sun damage and treating precancerous skin lesions."