Jul 28 2015
Syneron Medical Ltd., a global market leader in the aesthetic medical device marketplace, announced today that it 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.
Amit Meridor, Chief Executive Officer of Syneron Medical, said, "We are pleased to receive Korean regulatory clearance for PicoWay, expanding physician and patient access to this unique technology. 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."
Mr. Meridor added, "There has been strong interest in PicoWay since its introduction in late 2014 and subsequent U.S. FDA 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."
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 optimizes fracturing of tattoo ink or pigmentation. Tattoo colors known to be resistant to nanosecond devices can now be treated. There is also minimal risk of side effects, as the ultra-short pulses require low fluences to break up pigmentation. The innovative PicoWay Technology™ is the world's first dual wavelength picosecond laser and is integrated into a proven, reliable Candela platform that offers high reliability, demonstrated performance and low cost of ownership.