Sam Brusco, Associate Editor03.25.22
Dermatology solutions provider Cutera earned U.S. Food and Drug Administration (FDA) 510(k) clearance for AviClear, an energy-based device to treat mild, moderate, and severe acne.
The AviClear laser treatment’s trials demonstrated shorter, less intense, and more infrequent future breakout episodes. Clearance results continued to improve over time and no pain mitigation was needed.
AviClear resolves acne by selectively targeting sebocytes and suppressing sebum production.
“Existing device treatments for acne are neither long-lasting nor particularly effective,” Jeffrey S. Dover, MD, FRCPC, board-certified dermatologist and Cutera advisory board member told the press. “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,” said 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 will be made available to physicians over the course of this year.
The AviClear laser treatment’s trials demonstrated shorter, less intense, and more infrequent future breakout episodes. Clearance results continued to improve over time and no pain mitigation was needed.
AviClear resolves acne by selectively targeting sebocytes and suppressing sebum production.
“Existing device treatments for acne are neither long-lasting nor particularly effective,” Jeffrey S. Dover, MD, FRCPC, board-certified dermatologist and Cutera advisory board member told the press. “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,” said 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 will be made available to physicians over the course of this year.