MODEL 2100 ND:YAG SURGICAL LASER GASTROINTESTINAL

MODEL 2100 ND:YAG SURGICAL LASER GASTROINTESTINAL is an FDA 510(k)-cleared medical device (K861047) 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 June 16, 1986. Regulation: 8.