Nidek Co., Ltd.
Gamagori, JP
Nidek Co., Ltd. appears in FDA device records in Gamagori, JP. FDA records list 12 510(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
- 12
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 12 510(k) clearances for Nidek Co., Ltd. between 2013 and 2023. The busiest year on record is 2016, with 3. The most recent is 2023, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2013 | 1 |
| 2016 | 3 |
| 2017 | 2 |
| 2018 | 2 |
| 2019 | 2 |
| 2020 | 1 |
| 2023 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K221320 | Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing Software NAVIS-EX; Scanning Laser Ophthalmoscope Mirante [SLO Model] with Image Filing Software NAVIS-EX | OBO | Substantially Equivalent | |
| K203130 | Ophthalmic Yag Laser System YC-200 | HQF | Substantially Equivalent | |
| K192045 | Ophthalmic Yag Laser System YC-200 | HQF | Substantially Equivalent | |
| K190198 | Microperimeter MP-3, Microperimeter MP-3 Type S | HKI | Substantially Equivalent | |
| K181345 | Image Filing Software NAVIS-EX | NFJ | Substantially Equivalent | |
| K173980 | Specular Microscope CEM-530 | NQE | Substantially Equivalent | |
| K170302 | YELLOW LASER PHOTOCOAGULATOR YLC-500 | HQF | Substantially Equivalent | |
| K163564 | SLIT LAMP SL-2000 | HJO | Substantially Equivalent | |
| K152729 | MICROPERIMETER MP-3 | HKI | Substantially Equivalent | |
| K152603 | Green Laser Photocoagulator GYC-500 | HQF | Substantially Equivalent | |
| K151706 | Specular Microscope CEM- 530 | NQE | Substantially Equivalent | |
| K131894 | NIDEK GREEN LASER PHOTOCOAGULTOR MODEL GYC-1000 CONNECTED WITH THE ENDOPHOTOCOAGULATION DELIVERY UNIT | GEX | 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