FDA clears PicoSure for tattoo removal

December 31, 2012

The Food and Drug Administration has given Cynosure 510(k) clearance to market its PicoSure laser workstation for removing tattoos and pigmented lesions.

Washington - The Food and Drug Administration has given Cynosure 510(k) clearance to market its Pico- Sure laser workstation for removing tattoos and pigmented lesions.

Results of several studies indicate the device is effective at removing typically hard-to-remove pigments, according to a company statement.

A 15-patient study indicated that patients experience fewer side effects and don’t need as many treatments to achieve results compared with other devices. Results demonstrated total clearance of pigmented lesions after two treatments and greater than 75 percent clearance in tattoos for 75  percent of the patients after three to four treatments.

PicoSure delivers short-pulse bursts of photothermal energy to the pigmented area while leaving surrounding tissue unheated.

“The speed of the picoseconds  laser makes this technology ideal for aesthetic applications in which  large photomechanical stresses are applied to a particular target,” says Kenneth A. Arndt, M.D., one of the researchers involved in studying PicoSure