
Optomedic Medical Technologies , Ltd.
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KAPLAN PENDULASER 115 - A 15W CO2 SURGICAL LASER is an FDA 510(k)-cleared medical device (K950313) manufactured by Optomedic Medical Technologies , Ltd.. 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 March 23, 1995. Regulation: 8.