
Niic U.S.A., Inc.
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MODEL IR103 SURGICAL LASER SYSTEM is an FDA 510(k)-cleared medical device (K895247) manufactured by Niic U.S.A., Inc.. 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 November 15, 1989. Regulation: 8.