Medical Device Manufacturer · US , Redwood City , CA

Niic U.S.A., Inc. - FDA 510(k) Cleared Devices

16 submissions · 16 cleared · Since 1988
16
Total
16
Cleared
0
Denied

FDA 510(k) Regulatory Record - Niic U.S.A., Inc. General & Plastic Surgery

15 devices
1-15 of 15
Cleared Oct 02, 1990
MODEL IS102S ND:YAG SURGICAL LASER SYSTEM
K902133 · GEX
General & Plastic Surgery · 145d
Cleared Aug 14, 1990
MODELS IR103,IR107,IR104,IR205 (ADD'L APPLICATION)
K901205 · GEX
General & Plastic Surgery · 153d
Cleared Jun 29, 1990
NIIC MODEL 15 CARBON-DIOXIDE SURGICAL LASER SYSTEM
K902063 · GEX
General & Plastic Surgery · 57d
Cleared Jun 05, 1990
EXPANDED MARKETING OF MODELS IR104 & IR205 LASERS
K901204 · GEX
General & Plastic Surgery · 83d
Cleared Jan 23, 1990
NIIC LASER SYSTEM
K896988 · GEX
General & Plastic Surgery · 49d
Cleared Dec 13, 1989
MODEL: IR205 ARTICULATED SURGICAL LASER
K895581 · GEX
General & Plastic Surgery · 89d
Cleared Nov 16, 1989
MODEL NUMBER: IR204 CO2 SURGICAL LASER SYSTEM
K892359 · GEX
General & Plastic Surgery · 224d
Cleared Nov 16, 1989
MODEL IR107 50-WATT CARBON-DIOXIDE SURGICAL LASER
K895239 · GEX
General & Plastic Surgery · 87d
Cleared Nov 16, 1989
MODEL IR103 SURGICAL LASER SYSTEM
K895247 · GEX
General & Plastic Surgery · 87d
Cleared Aug 24, 1989
CO2 SURGICAL LASER SYSTEM
K894074 · GEX
General & Plastic Surgery · 77d
Cleared Nov 02, 1988
CO2 SURGICAL LASER SYSTEM MODEL #IR105
K882951 · GEX
General & Plastic Surgery · 111d
Cleared Nov 02, 1988
CO2 SURGICAL LASER SYSTEM MODEL #IR106
K882952 · GEX
General & Plastic Surgery · 111d
Cleared Aug 01, 1988
MODEL 130YZ CO2-YAG SURGICAL LASER SYSTEM
K880816 · GEX
General & Plastic Surgery · 166d
Cleared Apr 13, 1988
DX101 ULTRASONIC SURGICAL SYSTEM
K880814 · LFL
General & Plastic Surgery · 56d
Cleared Apr 13, 1988
DX101-T ULTRASONIC SURGICAL SYSTEM
K880815 · LFL
General & Plastic Surgery · 56d
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