Cutera Inc. said the U.S. Food and Drug Administration issued a 510(k) clearance of the AviClear device for the treatment of acne.
AviClear is a laser treatment. Cutera said it expects to make AviClear available to physicians throughout the U.S. over the course of 2022.
Cutera said that in addition to reducing existing acne, clinical trials show future breakout episodes are shorter, less intense and more infrequent following the AviClear procedure. Acne clearance results continue to improve over time, demonstrating long-term efficacy of the treatment, the company said. No pain mitigation was used or required by any clinical study participant, Cutera said.
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