MODEL 2100 ND:YAG SURGICAL LASER PULMONARY INDICAT

MODEL 2100 ND:YAG SURGICAL LASER PULMONARY INDICAT is an FDA 510(k)-cleared medical device (K861045) manufactured by Sharplan Industries, Inc.. 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 April 22, 1986. Regulation: 8.