
Sharplan Lasers, Inc.
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MODEL 4060 N ND:YAG LASER FOR UROLOGICAL USE is an FDA 510(k)-cleared medical device (K880193) manufactured by Sharplan Lasers, 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 April 13, 1988. Regulation: 8.