Niic U.S.A., Inc. - FDA 510(k) Cleared Devices
16
Total
16
Cleared
0
Denied
FDA 510(k) Regulatory Record - Niic U.S.A., Inc. General & Plastic Surgery ✕
15 devices
Cleared
Oct 02, 1990
MODEL IS102S ND:YAG SURGICAL LASER SYSTEM
General & Plastic Surgery
145d
Cleared
Aug 14, 1990
MODELS IR103,IR107,IR104,IR205 (ADD'L APPLICATION)
General & Plastic Surgery
153d
Cleared
Jun 29, 1990
NIIC MODEL 15 CARBON-DIOXIDE SURGICAL LASER SYSTEM
General & Plastic Surgery
57d
Cleared
Jun 05, 1990
EXPANDED MARKETING OF MODELS IR104 & IR205 LASERS
General & Plastic Surgery
83d
Cleared
Jan 23, 1990
NIIC LASER SYSTEM
General & Plastic Surgery
49d
Cleared
Dec 13, 1989
MODEL: IR205 ARTICULATED SURGICAL LASER
General & Plastic Surgery
89d
Cleared
Nov 16, 1989
MODEL NUMBER: IR204 CO2 SURGICAL LASER SYSTEM
General & Plastic Surgery
224d
Cleared
Nov 16, 1989
MODEL IR107 50-WATT CARBON-DIOXIDE SURGICAL LASER
General & Plastic Surgery
87d
Cleared
Nov 16, 1989
MODEL IR103 SURGICAL LASER SYSTEM
General & Plastic Surgery
87d
Cleared
Aug 24, 1989
CO2 SURGICAL LASER SYSTEM
General & Plastic Surgery
77d
Cleared
Nov 02, 1988
CO2 SURGICAL LASER SYSTEM MODEL #IR105
General & Plastic Surgery
111d
Cleared
Nov 02, 1988
CO2 SURGICAL LASER SYSTEM MODEL #IR106
General & Plastic Surgery
111d