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.