ESPADA Acne-Clearing Blue Light Pen

ESPADA Acne-Clearing Blue Light Pen is an FDA 510(k)-cleared medical device (K162450) manufactured by Foreo, Inc.. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 29, 2016. Regulation: 8.