OPTICAL INTEGRITY GENERAL SHAPED FIBER

OPTICAL INTEGRITY GENERAL SHAPED FIBER is an FDA 510(k)-cleared medical device (K022338) manufactured by Optical Integrity, 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 October 15, 2002. Regulation: 8.