Fraxel dual laser system receives FDA clearance for actinic keratosis treatment

Sept. 21, 2010
Solta Medical announced that its Fraxel re:store dual laser system, which features a thulium (Tm) fiber laser with a 1927 nm wavelength, has obtained FDA 510(k) clearance for treating actinic keratosis (AK), a pre-cancerous skin condition that occurs due to sun exposure.

Solta Medical's (Hayward, CA) Fraxel re:store dual laser system, which features a thulium (Tm) fiber laser with a 1927 nm wavelength, has obtained FDA 510(k) clearance for treating actinic keratosis (AK), a pre-cancerous skin condition that occurs due to sun exposure.

According to a six-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. None of the subjects experienced any adverse reactions due to the treatment.

Stephen J. Fanning, Solta Medical’s CEO, President and Chairman of the Board, stated that Solta continues 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 pre-cancerous skin lesions, he said.

Source: Solta Medical

Posted by Lee Mather

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