DERMWIRE Exclusive: FDA Clears Cutera’s AviClear Acne Device

Cutera’s AviClear is the first energy device to receive a nod for the treatment of mild, moderate, and severe acne.

The U.S. Food and Drug Administration has cleared granted 510(k) clearance to Cutera’s AviClear acne device.

This is the first energy device to receive a nod for the treatment of mild, moderate, and severe acne.

AviClear targets acne at the source by selectively targeting the sebocytes and suppressing sebum production. In addition to reducing existing acne, clinical trials show that future breakout episodes are shorter, less intense, and more infrequent following the AviClear procedure. Further, acne clearance results continue to improve over time, demonstrating the long-term efficacy of this novel treatment. Importantly, no pain mitigation was utilized or required by any clinical study participant.

“AviClear significantly shifts the treatment paradigm for acne by offering a safe, drug-free, and effective alternative to what is currently available,”  David Goldberg, MD, JD clinical-trial investigator for AviClear, tells Dermwire.  “I am excited about this device because it has an easy user interface and no significant adverse events were observed in the clinical trials, similarly, I know my patients will be thrilled about this new treatment because it can be performed on all skin types, any time of year, and the results are long-lasting.”

“Existing device treatments for acne are neither long-lasting nor particularly effective,” saya Jeffrey S. Dover, MD, FRCPC, board-certified dermatologist and Cutera advisory board member in a news release. “Topical therapies yield temporary results and oral medications present several challenges. AviClear offers patients a safe, well-tolerated, drug-free approach with durable results, which significantly shifts the treatment paradigm for acne.”

"Physicians and patients have long sought a modern alternative to the acne pills, peels and topicals that have been static for nearly 30 years,” adds David Mowry, CEO of Cutera. "Developed with extensive physician and patient input, AviClear was created to redefine the treatment of acne – all without a prescription.”

AviClear is expected to be made available to physicians throughout the United States over the course of 2022. Doctors and consumers are encouraged to visit www.AviClear.com and sign up for updates on product availability and local treatment providers.