FDA OKs Solta device for treating actinic keratosis

October 5, 2010

Solta Medical’s Fraxel re:store Dual laser has received Food and Drug Administration 510(k) clearance for the treatment of actinic keratosis (AKs), PRNewswire reports.

Hayward, Calif. - Solta Medical’s Fraxel re:store Dual laser has received Food and Drug Administration 510(k) clearance for the treatment of actinic keratosis (AKs), PRNewswire reports.

According to the company, a six-month clinical study of 21 subjects at several dermatology centers around the country resulted in an 83.5 percent average reduction of AK lesions following treatment with the device’s 1,927 nm wavelength.

Treatments were shown to be effective on the face, arms, hands and chest area. Each subject underwent a series of two to four treatments, spaced two to four weeks apart. The study found improvement in skin texture and pigmentation following Fraxel treatment, and no adverse reactions were reported.