MODEL 2100 ND:YAG SURGICAL LASER UROLOGICAL INDICA

MODEL 2100 ND:YAG SURGICAL LASER UROLOGICAL INDICA is an FDA 510(k)-cleared medical device (K861046) manufactured by Sharplan Industries, 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 May 1, 1986. Regulation: 8.