From Skin and Aging, October 2010
SOLTA Medical Announces FDA 510(K) Clearance of Fraxel Restore Dual Laser System for the Treatment of Actinic Keratosis
Our Fraxel Dual System has been approved by the FDA for treatment of actinic keratosis:
"Solta Medical Inc. recently announced it has received FDA clearance of its Fraxel Restore Dual for the treatment of actinic keratoses (AKs). During a 6-month clinical study of 21 patients at several dermatology centers around the country, there was an 83.5% average reduction of AK lesions using the Fraxel Restore Dual's 1927-nm wavelength, according to the company. Treatments were shown to be effective both on and off the face, including the arms, hands and chest area. Each patient underwent a series of two to four treatments with the Fraxel Restore Dual that were spaced 2 to 4 weeks apart.
'In our study, we found the Fraxel Restore 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, in a press release. '...Fraxel was overwhelmingly well-tolerated by all the patients and offers the added benefit of improving a patient's 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."