Solta Medical of Hayward, CA has received 510(k) from the FDA for its Fraxel re:store Dual laser system to be used in the treatment of actinic keratosis (AK). The system uses a novel Thulium fiber laser (1927 nm) that has a more superficial focus in addition to a deep penetrating Erbium fiber laser (1550 nm). The Fraxel re:store Dual was found to perform satisfactorily during a six month multi-center clinical study (of surprisingly only 21 subjects), with an 82.5% average reduction of AK lesions.
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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.”
Press release: Solta Medical Announces FDA 510(k) Clearance of Fraxel re:store Dual Laser System for the Treatment of Actinic Keratosis…
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