Syneron Candela’s Picosecond Laser Wins FDA, Health Canada Nods

Syneron Candela’s PicoWay picosecond laser — previously indicated for tattoo removal — has won an expanded FDA indication for the treatment of pigmented lesions, and has received Health Canada clearance for both indications, the Israel-based devicemaker announced Monday.

A dual wavelength device, PicoWay uses a picosecond pulse, occurring at one trillionth of second, to create a high-energy, ultra-short photo-mechanical impact that breaks down tattoo ink or pigmentation.

“PicoWay offers our customers a 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 technology for more of their pigment-related procedures,” Syneron CEO Amit Meridor said. “Since launching the product, there has been strong interest in PicoWay and we expect the addition of the pigmented lesion indication will further enhance its attractiveness to customers.”

PicoWay features 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.

“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,” Syneron Candela North America William Griffing CEO said.

Founded in 2000, Syneron Candela markets aesthetic devices in 86 countries.