Avava Medical Receives 510(k) Clearance for Avava Device

Waltham, Mass.-based Avava Medical has received 510(k) clearance for its Avava laser for treatment of benign pigmented lesions of the skin, including hyperpigmentation.

The intradermal laser features the company’s Focal Point technology which can deliver energy at any depth with pinpoint accuracy. The device uses artificial intelligence to deliver three-dimensional treatments that break down lesions near the surface or deep under the skin.

The device delivers treatments “without pain, downtime or side effects,” says Avava CEO Irina Erenburg.

The new clearance marks the company’s second from the FDA for its new class of focused intradermal laser products.