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FDA clears PicoWay picosecond laser for tattoo removal

Syneron Medical announced that the U.S. Food and Drug Administration has granted 510(k) clearance of the PicoWay picosecond device for the removal of tattoos.

PicoWay, with 1,064-nm and 532-nm wavelengths, incorporates picosecond pulse duration to generate an ultra-short pulse and very high peak power of laser energy on the skin, creating a strong photo-mechanical impact that fractures tattoo ink, according to a company press release.

FDA clearance of the device was supported by the results of a prospective, multicenter study in which 86% of participants achieved at least 50% tattoo clearance after only three treatments based on blinded, independent review. The PicoWay treatment also presented a favorable safety profile with no device-related serious adverse events and low levels of pain or discomfort, according to the release.

PicoWay is cleared for use on all tattoo colors: the 532-nm wavelength can be used for red, yellow and orange, and the 1,064-nm wavelength can be used for black, brown, green, blue and purple.

The U.S. launch will begin immediately, following the launch of the product in the international market, which occurred in October, according to the release.