Niic U.S.A., Inc.
Redwood City, CA, US
Niic U.S.A., Inc. appears in FDA device records in Redwood City, CA. FDA records list 16 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 16
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 16 510(k) clearances for Niic U.S.A., Inc. between 1988 and 1990. The busiest year on record is 1990, with 6. The most recent is 1990, with 6.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1988 | 5 |
| 1989 | 5 |
| 1990 | 6 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K902133 | MODEL IS102S ND:YAG SURGICAL LASER SYSTEM | GEX | Substantially Equivalent | |
| K901205 | MODELS IR103,IR107,IR104,IR205 (ADD'L APPLICATION) | GEX | Substantially Equivalent | |
| K902063 | NIIC MODEL 15 CARBON-DIOXIDE SURGICAL LASER SYSTEM | GEX | Substantially Equivalent | |
| K901204 | EXPANDED MARKETING OF MODELS IR104 & IR205 LASERS | GEX | Substantially Equivalent | |
| K900185 | NIIC MODEL: DX901 ASPIRATION SYSTEM | JFL | Substantially Equivalent | |
| K896988 | NIIC LASER SYSTEM | GEX | Substantially Equivalent | |
| K895581 | MODEL: IR205 ARTICULATED SURGICAL LASER | GEX | Substantially Equivalent | |
| K895247 | MODEL IR103 SURGICAL LASER SYSTEM | GEX | Substantially Equivalent | |
| K895239 | MODEL IR107 50-WATT CARBON-DIOXIDE SURGICAL LASER | GEX | Substantially Equivalent | |
| K892359 | MODEL NUMBER: IR204 CO2 SURGICAL LASER SYSTEM | GEX | Substantially Equivalent | |
| K894074 | CO2 SURGICAL LASER SYSTEM | GEX | Substantially Equivalent | |
| K882952 | CO2 SURGICAL LASER SYSTEM MODEL #IR106 | GEX | Substantially Equivalent | |
| K882951 | CO2 SURGICAL LASER SYSTEM MODEL #IR105 | GEX | Substantially Equivalent | |
| K880816 | MODEL 130YZ CO2-YAG SURGICAL LASER SYSTEM | GEX | Substantially Equivalent | |
| K880815 | DX101-T ULTRASONIC SURGICAL SYSTEM | LFL | Substantially Equivalent | |
| K880814 | DX101 ULTRASONIC SURGICAL SYSTEM | LFL | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain