Cutera’s AviClear Acne Device Obtains FDA Clearance


[Image from Cutera]

Cutera (Nasdaq: CUTR) today announced that it has received 510(k) clearance from the FDA for its AviClear acne treatment device.

Cutera, based in Brisbane, Calif., designed AviClear as a laser treatment for the safe, over-the-counter reduction of existing acne, while also demonstrating that after use, future breakout episodes are shorter, less intense and rarer.

The company said in a press release that AviClear represents the only energy-based device to receive 510(k) clearance from the FDA for the treatment of mild, moderate and severe acne. The platform selectively targets sebocytes and suppresses sebum production to treat acne breakouts.

Cutera said clinical trials have shown that acne clearing results with the use of AviClear continue to improve over time, with no pain relief used or required by clinical study participants. The company will make AviClear available to physicians across the United States during 2022.

“Physicians and patients have long sought a modern alternative to acne pills, peels and topicals that have been static for nearly 30 years,” said Cutera CEO David Mowry. noted in the release. “Developed with extensive input from physicians and patients, AviClear was created to redefine acne treatment – all without a prescription.”

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