BAYLAB 3-Ply Surgical Mask (BEACON I)

BAYLAB 3-Ply Surgical Mask (BEACON I) is an FDA 510(k)-cleared medical device (K212302) manufactured by Baylab USA, LLC. 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 December 6, 2021. Regulation: 8.