Soliton, a medical device company using a Rapid Acoustic Pulse (RAP) platform technology licensed from The University of Texas on behalf of the MD Anderson Cancer Center, has filed for Special 510(k) Premarket Notification with the U.S. Food and Drug Administration (FDA) for its Generation II RAP device.
The Generation II RAP device is indicated for the same tattoo-removal therapy as the Generation I device, but is slightly modified for improved ease of use in the physician's office. Although, similar technology was utilized in the company’s pivotal cellulite and proof of concept keloid scar trials, only the tattoo-removal indication will be reviewed by the FDA in this submission.
The Special 510(k) filing states the device is indicated as an accessory to the 1,064 nm Q-switched laser for tattoo removal on the arms, legs and torso in Fitzpatrick Skin Type I-III individuals. Clinical trials have demonstrated that using the company’s 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.
For more information www.soliton.com...