FDA clears PicoSure for wrinkle treatment

October 14, 2014

The Food and Drug Administration has granted 510(k) clearance to Cynosure, allowing it to market its PicoSure laser workstation for the treatment of wrinkles.

The Food and Drug Administration has granted 510(k) clearance to Cynosure, allowing it to market its PicoSure laser workstation for the treatment of wrinkles.

The PicoSure Picosecond Laser Workstation utilizes its FOCUS lens array, a disposable energy delivery system, to treat rhytids. PicoSure in 2012 became the world’s first picosecond laser device to obtain clearance from the FDA for treatment of benign pigmented lesions and tattoo removal, according to a news release.

“This clearance complements our recently received approval to market PicoSure for the treatment of acne scars, and demonstrates the breadth of our FOCUS lens array technology to address additional high-volume indications,” Michael Davin, Cynosure chairman and CEO, said in a statement. “According to the independent industry research and analysis firm Medical Insight, worldwide sales for skin rejuvenation platforms are projected to grow at a compound annual growth rate of 8.2 percent through 2018 to $512.6 million. We believe this large addressable market represents a significant growth opportunity for Cynosure and provides another avenue to drive our disposables revenue.”

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