
Sharplan Lasers, Inc.
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SHARPLAN 1075 CO2 LASER is an FDA 510(k)-cleared medical device (K893206) 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 June 20, 1989. Regulation: 8.