FDA clears Solta device for skin pigmentation treatment

The Food and Drug Administration has given 510(k) clearance to Solta Medical for its Fraxel DUAL 1550/1927 laser system for the treatment of pigmented lesions such as lentigos and ephelides.

The DUAL laser system is indicated for use in dermatologic procedure that require coagulation of soft tissue and for skin resurfacing procedures. Other indications include treatment of actinic keratosis, melisma, periorbital wrinkles, acne scars and surgical scars.

“The additional FDA clearance for Fraxel DUAL is a breakthrough in the treatment, improvement and correction of undesired skin pigmentation. With the 1,927 wavelength, patients can see significant results with very little downtime,” said Roy Geronemus, M.D., director, Laser & Skin Surgery Center of New York, in a news release.

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