Soliton recently announced that the FDA has given their Generation II RAP device special 510(k) premarket notification clearance as an adjunct to lasers for tattoo removal, with a planned commercial launch in mid-2020.
Soliton, a medical device company based in Houston, TX, recently announced that the U.S. Food and Drug Administration (FDA) has given special 510(k) premarket notification clearance for their Generation II Rapid Acoustic Pulse (RAP) device as an adjunct to lasers for tattoo removal with, according to a press release.
The Generation II RAP device delivers the same technology as Generation I but has been modified to enhance how easy it is to use in a physician’s office.
The treatment approach works by first making an initial pass with the laser, which forms vacuole whitening. The RAP device uses acoustic shock wave pulses to clear the vacuoles and allows for multiple laser passes in a single treatment session.
“…within seconds, the RAP’s acoustic waves remove the vacuoles as well as further dispersing the ink pigment from the macrophages,” according to Soliton’s website. “Another laser pass is now immediately possible and may be followed by another RAP Device pass and still another laser pass.”
Without the RAP device, the same results could take up to several months to complete, according to the company.
Noting the device’s intended use as an accessory for the 1064 nm Q-Switched laser on black ink in Fitzpatrick Skin Types I-III, Soliton initially filled the 510(k) application on Feb. 10, 2020, and is planning its commercial launch in mid-2020.
Soliton intends to provide the Generation II RAP device to approximately 20 to 25 highly recognized dermatologists within the U.S. to gain feedback on the device, says Christopher Capelli, M.D., founder, president and CEO of Soliton, in the press release announcing the clearance.
While similar technology was used in the company’s pivotal cellulite and proof-of-concept keloid scar trials, only the tattoo removal indication was reviewed by the FDA for the submission and cleared for marketing.