Posted in | Laser | Medical Optics

Fraxel re:store Dual Laser System Receives FDA 510(k) Clearance

Solta Medical announced that its Fraxel re:store Dual laser system has obtained the FDA 510(k) clearance, for the actinic keratosis (AKs) treatment. Actinic keratosis is a precancerous skin condition that occurs due to the exposure of sun on the body parts including face.

The Fraxel re:store Dual laser system features 1927 nm wavelength, which makes it the first Thulium laser application in the market of aesthetics. The company’s Fraxel re:store Dual treatment delivers remarkable results in removing AKs.

Fraxel restore Dual Laser

According to a 6-month clinical study conducted on 21 individuals at many dermatology centers throughout the country, the usage of the Fraxel re:store Dual system’s 1927 nm wavelength showed an average AK lesion reduction of 83.5%. Treatment showed effective results on the face, as well as the chest area, hands, and arms.

Using the Fraxel re:store Dual laser, each subject was given two to four treatments, separated by a time gap of two to four weeks. The study showed significant improvement in pigmentation and skin texture after a Fraxel treatment. The subjects did not experience any adverse reactions due to the treatment.

Solta Medical’s Chief Executive Officer, President and Chairman of the Board, Stephen J. Fanning stated that they continue to develop advanced and safe anti-aging solutions for non-invasive aesthetic treatments. The FDA clearance of the Fraxel re:store Dual system allows them to offer physicians with an advanced technology for treating sun damage and precancerous skin lesions, Fanning said.


Tell Us What You Think

Do you have a review, update or anything you would like to add to this news story?

Leave your feedback