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. The company said breakout episodes are shorter, less intense and more infrequent following use.
Cutera said AviClear is the only energy-based device to receive FDA 510(k) clearance for the treatment of mild, moderate and severe acne. The platform selectively targets sebocytes and suppresses sebum production to treat acne outbreaks.
Cutera said clinical trials showed that acne clearance with the use of AviClear improves 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 a news release. “Developed with extensive physician and patient input, AviClear was created to redefine the treatment of acne – all without a prescription.”
Original Article: https://www.massdevice.com/cuteras-aviclear-acne-device-wins-fda-clearance/
