Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Niic U.S.A., Inc.

FDA 510(k) & PMA Approved Devices — 16 products

Total Devices16
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K902133 MODEL IS102S ND:YAG SURGICAL LASER SYSTEMGEX1990-10-02 View
510(k) K901205 MODELS IR103,IR107,IR104,IR205 (ADD'L APPLICATION)GEX1990-08-14 View
510(k) K902063 NIIC MODEL 15 CARBON-DIOXIDE SURGICAL LASER SYSTEMGEX1990-06-29 View
510(k) K901204 EXPANDED MARKETING OF MODELS IR104 & IR205 LASERSGEX1990-06-05 View
510(k) K900185 NIIC MODEL: DX901 ASPIRATION SYSTEMJFL1990-05-24 View
510(k) K896988 NIIC LASER SYSTEMGEX1990-01-23 View
510(k) K895581 MODEL: IR205 ARTICULATED SURGICAL LASERGEX1989-12-13 View
510(k) K895247 MODEL IR103 SURGICAL LASER SYSTEMGEX1989-11-16 View
510(k) K895239 MODEL IR107 50-WATT CARBON-DIOXIDE SURGICAL LASERGEX1989-11-16 View
510(k) K892359 MODEL NUMBER: IR204 CO2 SURGICAL LASER SYSTEMGEX1989-11-16 View
510(k) K894074 CO2 SURGICAL LASER SYSTEMGEX1989-08-24 View
510(k) K882951 CO2 SURGICAL LASER SYSTEM MODEL #IR105GEX1988-11-02 View
510(k) K882952 CO2 SURGICAL LASER SYSTEM MODEL #IR106GEX1988-11-02 View
510(k) K880816 MODEL 130YZ CO2-YAG SURGICAL LASER SYSTEMGEX1988-08-01 View
510(k) K880815 DX101-T ULTRASONIC SURGICAL SYSTEMLFL1988-04-13 View
510(k) K880814 DX101 ULTRASONIC SURGICAL SYSTEMLFL1988-04-13 View
↑