PROTEGE ER:YAG LASER SYSTEM AND ACCESSORIES

PROTEGE ER:YAG LASER SYSTEM AND ACCESSORIES is an FDA 510(k)-cleared medical device (K971912) manufactured by Xintec Corporation. 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 November 2, 1997. Regulation: 8.