LAGIS ENDOSCOPIC INSTRUMENTS

LAGIS ENDOSCOPIC INSTRUMENTS is an FDA 510(k)-cleared medical device (K090309) manufactured by Lagis Enterprises Co, Ltd.. 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 27, 2009. Regulation: 8.