FDA Clears PicoSure™ for Treatment of Acne Scars

Cynosure, Inc., a specialist in laser- and light-based aesthetic treatments for non-invasive and minimally invasive applications, has received FDA 510(k) clearance for its flagship PicoSure Picosecond Laser Workstation for the treatment of acne scars.


Cynosure develops and markets aesthetic treatment systems that enable plastic surgeons, dermatologists and other medical practitioners to perform a variety of non-invasive and minimally invasive procedures. These include removal of hair, treating vascular and benign pigmented lesions, remove multi-colored tattoos, revitalize the skin, liquefy and remove unwanted fat through laser lipolysis, reduce cellulite, clear nails infected by toe fungus and ablate sweat glands.

Cynosure’s product portfolio is composed of a broad range of energy sources including Alexandrite, diode, Nd: YAG, picosecond, pulse dye, and Q-switched lasers and intense pulsed light.

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. Now with the FOCUS lens array, the Company’s new disposable energy delivery system, it will be able to market its PicoSure system for treatment of acne scars.

Company comments

“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.”

Source: Cynosure, Inc.

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