EC-5000 EXCIMER LASER SYSTEM
FDA premarket approval P970053 · decided 1998-12-17
Approval details
- PMA number
- P970053
- Trade name
- EC-5000 EXCIMER LASER SYSTEM
- Generic name
- Excimer laser system
- Applicant
- Nidek Co., Ltd.
- Date received
- 1997-11-06
- Decision date
- 1998-12-17
- Days to decision
- 406 days
- Decision code
- APPR
- Product code
- LZS
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Gamagori
- Statement
- Approval for the Nidek EC-5000 Excimer Laser System. This device is indicated for photorefractive keratectomy (PRK) for the reduction or elimination of mild to moderate myopia in patients with the following three characterisitics: 1) In PRK treatments for the reduction or elimination of myopia in the low, moderate, or high ranges (-0.75 Diopters (D) to -13.00D) spherical equivalent (S.E.) at the spectacle plan, uncomplicated by refractive astigmatism (i.e., <0.75D in any meridian). 2) In patient
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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 |