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Niic U.S.A., Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
16
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K902133MODEL IS102S ND:YAG SURGICAL LASER SYSTEMOctober 2, 1990
K901205MODELS IR103,IR107,IR104,IR205 (ADD'L APPLICATION)August 14, 1990
K902063NIIC MODEL 15 CARBON-DIOXIDE SURGICAL LASER SYSTEMJune 29, 1990
K901204EXPANDED MARKETING OF MODELS IR104 & IR205 LASERSJune 5, 1990
K900185NIIC MODEL: DX901 ASPIRATION SYSTEMMay 24, 1990
K896988NIIC LASER SYSTEMJanuary 23, 1990
K895581MODEL: IR205 ARTICULATED SURGICAL LASERDecember 13, 1989
K895247MODEL IR103 SURGICAL LASER SYSTEMNovember 16, 1989
K892359MODEL NUMBER: IR204 CO2 SURGICAL LASER SYSTEMNovember 16, 1989
K895239MODEL IR107 50-WATT CARBON-DIOXIDE SURGICAL LASERNovember 16, 1989
K894074CO2 SURGICAL LASER SYSTEMAugust 24, 1989
K882951CO2 SURGICAL LASER SYSTEM MODEL #IR105November 2, 1988
K882952CO2 SURGICAL LASER SYSTEM MODEL #IR106November 2, 1988
K880816MODEL 130YZ CO2-YAG SURGICAL LASER SYSTEMAugust 1, 1988
K880815DX101-T ULTRASONIC SURGICAL SYSTEMApril 13, 1988
K880814DX101 ULTRASONIC SURGICAL SYSTEMApril 13, 1988