Nidek Co., Ltd.
FDA 510(k) & PMA Approved Devices — 12 products
Total Devices12
Categories7
Latest FDA decision2023-03-30
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | 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 | 2023-03-30 | View |
| 510(k) | K203130 | Ophthalmic Yag Laser System YC-200 | HQF | 2020-12-07 | View |
| 510(k) | K192045 | Ophthalmic Yag Laser System YC-200 | HQF | 2019-11-15 | View |
| 510(k) | K190198 | Microperimeter MP-3, Microperimeter MP-3 Type S | HKI | 2019-04-01 | View |
| 510(k) | K181345 | Image Filing Software NAVIS-EX | NFJ | 2018-07-19 | View |
| 510(k) | K173980 | Specular Microscope CEM-530 | NQE | 2018-03-14 | View |
| PMA | P970053 | Excimer laser system | LZS | 2018-01-12 | View |
| 510(k) | K170302 | YELLOW LASER PHOTOCOAGULATOR YLC-500 | HQF | 2017-06-23 | View |
| 510(k) | K163564 | SLIT LAMP SL-2000 | HJO | 2017-05-19 | View |
| 510(k) | K152729 | MICROPERIMETER MP-3 | HKI | 2016-06-06 | View |
| 510(k) | K152603 | Green Laser Photocoagulator GYC-500 | HQF | 2016-05-02 | View |
| 510(k) | K151706 | Specular Microscope CEM- 530 | NQE | 2016-03-17 | View |
No matching devices.