
Ion Laser Technology
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CL-5500 (UNMODIFIED DEVICE) PRECISION CURING UNIT (PCU) (MODIFIED OPTION) is an FDA 510(k)-cleared medical device (K950351) manufactured by Ion Laser Technology. 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.