SURGI-LIGHT DISPOSABLE SYSTEM FOR PULMONOLOGY USE

SURGI-LIGHT DISPOSABLE SYSTEM FOR PULMONOLOGY USE is an FDA 510(k)-cleared medical device (K875104) manufactured by Laserguide. This device is classified under the Ear, Nose, Throat specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 1, 1988. Regulation: 8.