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Solta Medical Announces FDA 510(k) Clearance of Fraxel re:store Dual Laser System for the Treatment of Actinic Keratosis
Date:9/16/2010

HAYWARD, Calif., Sept. 16 /PRNewswire/ -- 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 patient
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SOURCE Solta Medical, Inc.
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