FDA Clears SofWave’s Ultrasound Aesthetic Treatment

Israeli-based SofWave Medical received 510(k) clearance for its SofWave system, a non-invasive skin treatment device that uses ultrasound technology.

The device is used to reduce lines and wrinkles on the face, neck and chest, and is designed for patients who wish to avoid facial augmentation surgery.

The non-invasive skin treatment platform avoids patient downtime that results from surgery and combines “multiple proprietary innovations in ultrasound technology,” the company said.