FDA clears Soliton’s acoustic shock tattoo removal device

Soliton received FDA 510(k) clearance for its Rapid Acoustic Pulse tattoo removal device.

The device was indicated as an accessory to the 1064 nm Q-Switched laser for black ink tattoo removal from the arms, legs and torso in people with Fitzpatrick Skin Type I-III.

“Receiving clearance from the FDA, while inline with our expectation, is nonetheless gratifying and validating, representing a bedrock for the commercialization plan of our RAP technology,” president, CEO and co-founder Chris Capelli said in a press release. “This clearance to market allows us to begin the transition from R&D to expanded product development and commercialization within the tattoo removal segment.”

Soliton’s shockwave device delivers up to 100 pulses per second through a replaceable treatment cartridge. It safely converts 3,000 V at 3,000 amps and has a short rise time and fall time. As a result, microscopic mechanical disruption can target the cellular level structure and vacuoles. Each acoustic pulse has a negative pressure component that is thin enough for laser therapy delivery.

Clinical trials showed that the Rapid Acoustic Pulse device removes tattoos in 2-3 office visits. Tattoo owners in the trial reported needing 10 or more office visits in the laser-only standard of care.

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