PROTEGE II ER: YAG LASER SYSTEM AND ACCESSOIES (UPGRADE)

PROTEGE II ER: YAG LASER SYSTEM AND ACCESSOIES (UPGRADE) is an FDA 510(k)-cleared medical device (K981627) 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 July 30, 1998. Regulation: 8.