WATERLASE, VERSION 3.0

WATERLASE, VERSION 3.0 is an FDA 510(k)-cleared medical device (K081589) 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 June 12, 2008. Regulation: 8.