EC-5000 EXCIMER LASER SYSTEM
FDA premarket approval P970053/S016 · decided 2017-06-08
Approval details
- PMA number
- P970053
- Supplement
- S016
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- EC-5000 EXCIMER LASER SYSTEM
- Generic name
- Excimer laser system
- Applicant
- Nidek Co., Ltd.
- Date received
- 2017-03-13
- Decision date
- 2017-06-08
- Days to decision
- 87 days
- Decision code
- APPR
- Product code
- LZS
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Gamagori
- Statement
- Approval for changes to the Final Fit V1.11 and V1.12 Custom Ablation Treatment Planning Software for Nidek EC-5000 Excimer Laser System. The updated Final Fit software is V1.13.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| 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 (K221320) | Nidek Co., Ltd. | 2023-03-30 |
| Ophthalmic Yag Laser System YC-200 (K203130) | Nidek Co., Ltd. | 2020-12-07 |
| Ophthalmic Yag Laser System YC-200 (K192045) | Nidek Co., Ltd. | 2019-11-15 |
| Microperimeter MP-3, Microperimeter MP-3 Type S (K190198) | Nidek Co., Ltd. | 2019-04-01 |
| Image Filing Software NAVIS-EX (K181345) | Nidek Co., Ltd. | 2018-07-19 |
| Specular Microscope CEM-530 (K173980) | Nidek Co., Ltd. | 2018-03-14 |
| YELLOW LASER PHOTOCOAGULATOR YLC-500 (K170302) | Nidek Co., Ltd. | 2017-06-23 |
| SLIT LAMP SL-2000 (K163564) | Nidek Co., Ltd. | 2017-05-19 |