MEROCEL(R) LASER-GUARD(TM)

MEROCEL(R) LASER-GUARD(TM) is an FDA 510(k)-cleared medical device (K910463) manufactured by Merocel Corp.. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 5, 1992. Regulation: 8.