
Laser Surgical Systems
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SUREPEN(TM) DISPOSABLE ACTIVE ELECTRODES is an FDA 510(k)-cleared medical device (K925266) manufactured by Laser Surgical Systems. 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 14, 1993. Regulation: 8.