FDA Clears Syneron Candela's PicoWay Picosecond Laser for Treatment of Pigmented Lesions


The FDA cleared Syneron Medical Ltd.’s PicoWay® picosecond laser for the treatment of pigmented lesions. The PicoWay picosecond laser previously received FDA clearance for the removal of tattoos in November 2014 and was launched in the US late in the fourth quarter 2014.

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. The PicoWay Technology™ is integrated into a proven, reliable Candela platform which offers high reliability, superior performance and low cost of ownership.

Amit Meridor, Chief Executive Officer of Syneron Medical, said, "PicoWay offers our customers a reliable and easy-to-use system featuring the shortest picosecond pulse and the highest peak power on the market. The expansion of PicoWay's FDA clearance to include pigmented lesions further enhances the utility of the system, allowing practitioners to offer this next-generation technology for more of their pigment-related procedures. It is also indicative of our commitment to add new applications that leverage the PicoWay technology for other treatments. Since launching the product late last year, there has been strong interest in PicoWay and we expect the addition of the pigmented lesion indication will further enhance its attractiveness to customers."

The Company also announced Health Canada clearance of the PicoWay picosecond laser for the treatment of pigmented lesions and tattoo removal. PicoWay is a dual wavelength device, with 532nm and 1064nm wavelengths, which utilizes proprietary PicoWay Technology to generate picosecond pulses for the treatment of pigmented lesions and tattoos of all colors. The Health Canada clearance is for all tattoo colors: red, yellow and orange for the 532nm wavelength; black, brown, green, blue and purple for the 1064nm wavelength.

The launch of PicoWay in Canada will begin during the second quarter 2015, building on the launch of the product in the US and other international markets during the fourth quarter 2014. The Company sells its products in Canada through its direct North American sales organization.

William Griffing, Chief Executive Officer of Syneron Candela North America, said, "Based on the strong early reception to PicoWay, we believe we are well positioned to drive adoption in Canada based on our unique PicoWay technology, strong Candela brand, and broad existing customer base."


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