Nidek, Inc.
El Toro, CA, US
Nidek, Inc. appears in FDA device records in El Toro, CA. FDA records list 9 510(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
- 9
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 9 510(k) clearances for Nidek, Inc. between 1989 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 |
|---|---|
| 1989 | 3 |
| 1990 | 6 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K904402 | NIDEK INC. MODEL AC-2000 DERM | GEX | Substantially Equivalent | |
| K900925 | NIDEK, INC. MODEL ADC-8000 DERM | GEX | Substantially Equivalent | |
| K900890 | NIDEK MODEL AKC-8000 OPHTHALMIC LASER PHOTOCOAGULA | GEX | Substantially Equivalent | |
| K901481 | MODEL YC-1200/PHOTOCOAGULATOR OPHTHALMIC LASER | GEX | Substantially Equivalent | |
| K900166 | NIDEK, INC. MODELS YC-1100 OPHTHALMIC LASERS | GEX | Substantially Equivalent | |
| K900165 | NIDEK, INC. BIO-DC LASER DELIVERY SYSTEM | GEX | Substantially Equivalent | |
| K895196 | MODEL DC-1200 DIODE LASER PHOTOCOAGULATOR | HQF | Substantially Equivalent | |
| K893987 | NIDEK MODEL YC-1200 | LXS | Substantially Equivalent | |
| K892204 | NIDEK INC. MODELS YC-2000 & 3000 OPHTHALMIC LASERS | LXS | 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