Solta Medical Receives New FDA 510(k) Clearance For Dual Laser System

The Fraxel DUAL 1550/1927 laser system has received an additional FDA 510(k) clearance for treatment of pigmented lesions, including lentigos, solar lentigos and ephelides, Solta Medical announced recently.

“The additional FDA clearance for Fraxel DUAL is a breakthrough in the treatment, improvement and correction of undesired skin pigmentation,” Roy G. Geronemus, MD, director of the Laser & Skin Surgery Center of New York and a clinical professor of dermatology at New York University Medical Center, said in a press release. “With the 1927 nm wavelength, patients can see significant results with very little downtime.”

The fractional laser system safely penetrates skin to the dermis without disrupting the protective outer barrier, providing maximum safety and recovery time, according to the release. The device also has indications for coagulation of soft tissue and for skin resurfacing procedures used to treat actinic keratosis, melasma, periorbital wrinkles, acne and surgical scars.

“With the additional FDA clearance of our Fraxel DUAL system, we are enhancing the cutting-edge technology … in treating pigmentation and actinic keratosis caused by sun damage,” Stephen J. Fanning, president and CEO of Solta Medical, said in the release.