Laser treatment for sunspots gets FDA approval
Cynosure’s new technology is called PicoSure, and was given FDA clearance at the end of last year, paving the way for the launch of the technology onto the US market now.
"FDA clearance of PicoSure is a major milestone that caps nearly a decade of research and development at Cynosure to commercialize the world's first safe and effective picosecond aesthetic laser specifically designed for the removal of tattoos and benign pigmented lesions," said President and CEO Michael Davin.
"PicoSure accomplishes this by delivering short-pulse bursts of energy to the skin in trillionths of a second. The FDA clearance of PicoSure creates a first-mover advantage for Cynosure to treat a large and vastly underserved market."
PicoSure took a decade to develop
Having been in development for nearly a decade, PicoSure is claimed to be the first safe and effective picosecond aesthetic laser designed to treat dark and sun spots.
The company says that the secret to the treatment’s effectiveness is shorter picosecond pulses that break up the targeted pigment, without damaging surrounding areas or forming rough edges.
As part of efforts to secure the FDA approval, the company has conducted a series of clinical trial that both prove the treatment’s safety as well as its efficacy in the treatment of sunspots, as well as the removal of tattoos.
Proven treatment for sunspots and tattoos
Those tests were carried out by Roy Geronemus, M.D., who is also director of the Laser & Skin Surgery Center of New York, and who performed a series of studies in which subjects with both pigmented legions such as sunspots and tattoos were treated with PicoSure.
"PicoSure delivers photothermal and significant photomechanical effects to the tattoo or pigmented lesion while leaving the surrounding tissue unheated," said Kenneth Arndt, M.D., director of the skin care practice, PicoSure.
"The speed of the picosecond laser makes this technology ideal for aesthetic applications in which large photomechanical stresses are applied to a particular target."