Monday, November 28, 2022

Soliton Files Special 510(k) with FDA for its Generation II RAP Acoustic Pulse Device

Soliton, Inc., a medical device company with a novel and proprietary platform technology licensed from The University of Texas on behalf of the MD Anderson Cancer Center today announced that it has filed for Special 510(k) Premarket Notification with the U.S. Food and Drug Administration (“FDA”) for its Generation II Rapid Acoustic Pulse (“RAP”) device.

The Generation II RAP device delivers the same tattoo-removal therapy as the Generation I device but is slightly modified for improved ease of use in the physician’s office. The Generation II RAP device constitutes the underlying technology of the RAP device that will be deployed in the limited U.S. commercial launch planned for mid-year 2020.  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 and enabled during this initial launch.

The Special 510(k) filing states the device is indicated as an accessory to the 1064 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.

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