
Medart Corp.
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UNI-LASER 450P CO2 LASER SYSTEM & ACCESSORIES is an FDA 510(k)-cleared medical device (K991297) manufactured by Medart Corp.. 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 July 11, 1999. Regulation: 8.