HALUX IRIS EXAMINATION AND SURGICAL LAMP

HALUX IRIS EXAMINATION AND SURGICAL LAMP is an FDA 510(k)-cleared medical device (K053364) manufactured by Waldmann Lighting. 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 February 22, 2006. Regulation: 8.