The Generation II RAP device features the same tattoo-removal technology as the first generation but is modified for improved ease of use in physician offices.
“The FDA clearance of our Generation II RAP device marks yet another milestone on Soliton’s path towards commercialization, specifically this year’s strategic launch for tattoo removal,” president and CEO Christopher Capelli said in a news release. ” We initially intend to provide this generation of the device to approximately 20-25 of the top dermatologists within the United States and look forward to the resulting physician feedback and market data regarding cartridge utilization.”
The special 510(k) filing was submitted to the FDA on February 10 and lists the device as an accessory to the 1064 nm Q-Switched laser for black ink tattoo remove in Fitzpatrick Skin Type I-III patients.
Soliton in July last year raised $9 million in a private placement for its acoustic tattoo removal aid it was developing at the time.