FDA Grants 510(k) Clearance to Cutera’s AviClear Acne Device

Cutera has received the FDA’s 510(k) clearance for its AviClear device for treatment of mild, moderate and severe acne.

In clinical trials, the non-prescription laser acne treatment demonstrated that “future breakout episodes are shorter, less intense, and more infrequent,” the company said.

The acne clearance continued to improve over time and no pain mitigation was required by any clinical study participant, Cutera said.