Back to All NewsSoliton Files Special 510(k) with FDA for its Generation II RAP Device
Posted By American Med Spa Association, Monday, February 17, 2020
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Soliton, Inc., a medical device company with a proprietary platform technology licensed from The University of Texas on behalf of the MD Anderson Cancer Center, has announced that it has filed for Special 510(k) Premarket Notification with the U.S. Food and Drug Administration 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.
Read more at PR Newswire >>
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.
Read more at PR Newswire >>
