Fraxel Dual Laser Receives FDA 510(k) Clearance For Pigmented Lesions

The Fraxel DUAL 1550/1927 system from Solta Medical ( has received a new FDA 510(k) clearance for the treatment of pigmented lesions such as—but not limited to—lentigos (age spots), solar lentigos (sun spots) and ephelides (freckles).
“The Fraxel DUAL 1550/1927 provides patients superior antiaging results, specifically when treating pigmentation of the skin caused by sun exposure,” said Roy G. Geronemus, MD, director of the Laser & Skin Surgery Center of New York and clinical professor of dermatology at New York University Medical Center. “The additional FDA clearance for Fraxel DUAL is a breakthrough in the treatment, improvement and correction of undesired skin pigmentation. With the 1927nm wavelength, patients can see significant results with very little downtime.”
In addition to the treatment of pigmented lesions, the Fraxel DUAL system is indicated for use in dermatological procedures requiring the coagulation of soft tissue, as well as for skin resurfacing procedures. Specific additional indications include actinic keratosis (AKs), melasma, treatment of periorbital wrinkles, acne scars and surgical scars.

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