FDA clearance for facial lines and wrinkles for Sofwave

Sofwave Medical has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Sofwave system.

The Sofwave device is indicated for use as a non-invasive aesthetic treatment to improve facial lines and wrinkles. The 510(k) clearance was supported by a blinded study. According to investigators’ evaluations, 86% of subjects demonstrated improvement in wrinkle appearance of at least one Elastosis Score, while the blinded reviewers identified correctly the pre- and post-treatment photographs for 78% of the treated subjects.