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# Soliton 510(k) for Rapid Tattoo Removal
- URL: https://www.fdaweb.com/soliton-510-k-for-rapid-tattoo-removal/
- Published: 2019-03-21T12:00:00.000Z
- Updated: 2026-09-15T01:14:35.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5143675

Soliton has submitted a 510(k) for the Rapid Acoustic Pulse (RAP) tattoo removal device. The device is indicated as an accessory to the 1064 nm Q-Switched laser for black ink tattoo removal on the arms, legs and torso in Fitzpatrick Skin Type I-III individuals. The company says the submission includes clinical data showing that the RAP device, in conjunction with a Q-switched laser, “allows for multiple passes of laser treatment in a single treatment session, resulting in accelerated fading in comparison to stand-alone laser treatment.” The current standard of care for tattoo removal is to use a Q-switched (pulsed) laser to ablate the tattoo ink particles into pieces small enough for the body’s natural processes to remove them, which can require up to 10 or more office visits to achieve acceptable results.