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Syneron Medical wins FDA approval for short-wavelength PicoWay laser

MDBR Staff Writer Published 26 July 2016

Syneron Medical has secured approval from the US Food and Drug Administration (FDA) for a new ultra-short 785nm wavelength laser for its PicoWay picosecond laser device.

The PicoWay system is an aesthetic laser system designed for the removal of tattoos of all colors and types and treating pigmented lesions.

The system secured FDA clearance to remove tattoos in November, 2014 and for the treatment of pigmented lesions in April 2015.

The new ultra-short 785nm wavelength laser uses a titanium sapphire laser for the removal of blue and green inks.

Its approval was based on a 15 patient study, covering 22 tattoos, of which 18 were blue and green inks.

Independent board-certified physicians carried out blinded assessment of tattoo clearance and demonstrated that 83% of the treated blue/green tattoos had good to complete treatment response after 2 PicoWay treatments with the 785nm wavelength.

Investigator evaluation of tattoo clearance showed same results to blinded evaluation findings.

Syneron said treatment complications were not reported, and PicoWay treatments were generally associated with no discomfort to mild discomfort for the majority of cases.

Syneron Medical CEO Amit Meridor said: “With the addition of this third wavelength, PicoWay can now provide practices with the ability to provide comprehensive removal and treatment of all colors of tattoos and skin pigmentation.

“We look forward to making this feature available to new and existing PicoWay customers in the U.S. beginning in the fourth quarter.” 

Image: The addition of the new 785nm wavelength expands the capabilities of the PicoWay picosecond laser from Syneron Candela, making it possible to remove all tattoo ink colors including blue and green. Photo: courtesy of PRNewsFoto/Syneron Medical Ltd.