
Niic U.S.A., Inc.
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EXPANDED MARKETING OF MODELS IR104 & IR205 LASERS is an FDA 510(k)-cleared medical device (K901204) 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 June 4, 1990. Regulation: 8.