MODEL 2100 ND:YAG SURGICAL LASER GYNECOLOGICAL USE

MODEL 2100 ND:YAG SURGICAL LASER GYNECOLOGICAL USE is an FDA 510(k)-cleared medical device (K871579) manufactured by Sharplan Lasers, Inc.. This device is classified under the Obstetrics/Gynecology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 15, 1987. Regulation: 8.