Cutera (Nasdaq:CUTR) announced today that it received FDA 510(k) clearance for its AviClear acne treatment device.
Brisbane, California-based Cutera designed AviClear as a laser treatment for the safe, prescription-free reduction of existing acne, while it also demonstrates that, following use, future breakout episodes are shorter, less intense and more infrequent.
The company said in a news release that AviClear represents the only energy-based device to receive FDA 510(k) clearance for the treatment of mild, moderate and severe acne. The platform selectively targets the sebocytes and suppresses sebum production to treat acne outbreaks.
Cutera said that clinical trials showed that acne clearance results with the use of AviClear continue to improve over time, with no pain mitigation utilized or required by any clinical study participant. The company will make AviClear available to physicians throughout the U.S. over the course of 2022.
“Physicians and patients have long sought a modern alternative to the acne pills, peels and topicals that have been static for nearly 30 years,” Cutera CEO David Mowry said in the release. “Developed with extensive physician and patient input, AviClear was created to redefine the treatment of acne – all without a prescription.”