
Zap Lasers, LLC
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SOFTLASE G2-SURGICAL DIODE LASER SYSTEM is an FDA 510(k)-cleared medical device (K021227) manufactured by Zap Lasers, LLC. 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 25, 2002. Regulation: 8.