Solta Medical Announces FDA 510(k) Clearance of New Fraxel re:store Dual Laser System

Solta Medical, Inc., recently announced it has received FDA 510(k) clearance for the new Fraxel re:store Dual laser system. The Fraxel re:store Dual system adds a novel 1927 nm wavelength, the first ever application of a Thulium laser in the aesthetics market, to the company’s existing technology. The new Fraxel re:store Dual system is optimized for both on face and large body areas to address clearance of pigmentation and other superficial skin conditions all in a single treatment, according to Solta Medical.

Prior to the non-ablative Fraxel re:store Dual system, laser skin resurfacing procedures were largely limited to the face. The expanded versatility of the Fraxel re:store Dual system, with the addition of the new 1927 nm wavelength, increases the areas of the body that physicians can treat.

According to Solta Medical, the new Fraxel re:store Dual system provides significant enhancements that enable physicians to better address pigmentation and other dyschromia on the entire body. According to the company, the Fraxel re:store Dual system features a dual fiber laser technology in one system, an accelerated clearance of unwanted pigmentation, and ease of operation and improved patient comfort with focal cooling built directly into the hand piece. It also allows for treatment of larger and multiple body areas in a single session with the addition of the 1927 nm wavelength and increased procedure speed by 25% with newly improved scanner design.

The Fraxel re:store 1550 nm laser is FDA cleared for skin resurfacing and for the treatment of pigmented lesions, acne scars, melasma, mild to moderate periorbital rhytids, surgical scars and actinic keratosis. The Fraxel re:store 1927 nm laser is FDA cleared for dermatological procedures requiring the coagulation of soft tissue.

Skin and Aging

Volume 17 - Issue 11 - November 2009