WATERLASE AND WATERLASE MD

WATERLASE AND WATERLASE MD is an FDA 510(k)-cleared medical device (K071363) manufactured by Biolase Technology, 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 February 11, 2008. Regulation: 8.