CELLERATION MIST THERAPY SYSTEM 5.1

CELLERATION MIST THERAPY SYSTEM 5.1 is an FDA 510(k)-cleared medical device (K050129) manufactured by Celleration, 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 May 16, 2005. Regulation: 8.