
Sharplan Lasers, Inc.
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MODIFIED MODEL 2100 ND:YAG LASER is an FDA 510(k)-cleared medical device (K881848) 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 May 10, 1988. Regulation: 8.