Cynosure gets marketing approval from FDA for PicoSure Picosecond Laser Workstation

Jul 24 2014

Cynosure, Inc. (NASDAQ: CYNO), a leader in laser- and light-based aesthetic treatments for non-invasive and minimally invasive applications, today announced that it has received FDA 510(k) clearance to market its flagship PicoSure™ Picosecond Laser Workstation for the treatment of acne scars with the FOCUS lens array, the Company's new disposable energy delivery system. In the fourth quarter of 2012, PicoSure became the world's first picosecond device to receive FDA clearance for the removal of tattoos and benign pigmented lesions.

"The clearance to treat acne scarring with PicoSure represents a significant milestone in our strategy to pursue expanded indications that demonstrate the breadth of this technology," said Cynosure President and Chief Executive Officer Michael Davin. "PicoSure continues to be well received by physicians and consumers in the U.S. as well as internationally. The treatment of acne scarring represents a large global market, and we believe that approval of PicoSure effectively positions us to capitalize on this opportunity. At the same time, we continue to pursue new FDA marketing clearances for PicoSure in additional indications such as the treatment of wrinkles."

"Our FOCUS lens array microscopically concentrates laser energy on small treatment areas of tissue while stimulating collagen production and remodeling," Davin said. "With its unique pulse format, we believe FOCUS technology presents the opportunity for physicians to offer highly customizable treatments for their patients."