C100 WRINKLE REDUCTION DEVICE

C100 WRINKLE REDUCTION DEVICE is an FDA 510(k)-cleared medical device (K112362) manufactured by Silver Bay, 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 August 13, 2012. Regulation: 8.