SOFTLASE PRO, ORTHOLASE AND HYGIENELASE

SOFTLASE PRO, ORTHOLASE AND HYGIENELASE is an FDA 510(k)-cleared medical device (K091796) manufactured by Zap Lasers, 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 July 30, 2009. Regulation: 8.