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

The Generation II RAP device delivers tattoo-removal therapy. Photo credit: Antonio_Diaz/iStock/Getty Images Plus

Soliton 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 will be deployed in the limited U.S. commercial launch planned for mid-year 2020. Only the tattoo removal indication will be reviewed by the FDA in this submission and enabled during this initial launch. Clinical trials have demonstrated that using the 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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