Solta's Fraxel re:store Dual laser cleared by FDA
This article was originally published in Clinica
Executive Summary
The US FDA has granted 510(k) clearance for Solta Medical's Fraxel re:store Dual laser system for the treatment of actinic keratosis. This precancerous skin condition is caused by sun exposure, and can progress to squamous cell carcinoma, a cancer that occurs in many organs including the skin. Actinic keratosis lesions can occur on the face, arms, hands and chest. A six-month clinical trial found that the laser removed 83.5% of lesions in 21 patients – similar to the rate seen with other treatment options such as topical therapy. However, Fraxel re:store was "overwhelmingly well tolerated" and improved patients' overall skin quality, Hayward, California-based Solta claimed.