Syneron Earns Korean OK for Picosecond Laser

Irvine, Calif.-based Syneron Medical Ltd., which makes aesthetic devices, has received Korean Ministry of Food and Drug Safety (MFDS) regulatory clearance for the Picoway picosecond laser. With this regulatory clearance, the company can fulfill Picoway orders from its Korean distribution partner, with additional commercial launch activity in Korea anticipated later in the third quarter 2015. This approval comes on the heels of U.S. and Canada regulatory nods for the technology.

“We are pleased to receive Korean regulatory clearance for Picoway, expanding physician and patient access to this unique technology,” said CEO Amit Meridor. “Korea is an important market where we have a strong commercial history and Picoway provides a much desired treatment option for discerning Korean physicians and patients, who are looking for a breakthrough technology that delivers a high degree of efficacy, demonstrated by dedicated Asian-market clinical studies.”

Meridor added that there has been strong interest in Picoway since its introduction in late 2014 and subsequent U.S. Food and Drug Administration clearance for benign pigmented lesions and tattoo removal. “We expect continued momentum as we introduce the system to more customers and gain new regulatory clearances around the world,” he said.

Picoway incorporates picosecond (one trillionth of a second) pulse duration to generate an ultra-short pulse and very high peak power of laser energy on the skin. The high energy, ultra-short picosecond laser pulse creates a strong photo-mechanical impact that is meant to optimize fracturing of tattoo ink or pigmentation. Tattoo colors known to be resistant to nanosecond devices can be treated with Picoway, the company claims.