Soliton Files Special 510(k) for Tattoo Removal Device

Soliton has submitted a special 510(k)application for an upgraded version of its rapid acoustic pulse (RAP) tattoo removal device to modify it for easier use in a physician’s office.

The device is indicated as an accessory to the 1064 nm Q-switched laser for removing arm, leg and torso tattoos in patients with sensitive skin types 1 through 3 on the Fitzpatrick skin phototype classification.

Clinical trials have shown that using Soliton’s RAP device with a Q-switched laser offers accelerated tattoo fading compared to using laser treatment alone, the company said.