ND:YAG POSTERIOR CAPSULOTOMY MODEL 100
FDA premarket approval P830062/S002 · decided 1985-02-14
Approval details
- PMA number
- P830062
- Supplement
- S002
- Trade name
- ND:YAG POSTERIOR CAPSULOTOMY MODEL 100
- Generic name
- Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary
- Applicant
- Nidek, Inc.
- Date received
- 1984-10-15
- Decision date
- 1985-02-14
- Days to decision
- 122 days
- Decision code
- APPR
- Product code
- LOI
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fremont, CA
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| OPD-STATION SOFTWARE (K050336) | Nidek, Inc. | 2005-08-24 |
| MULTI COLOR LASER PHOTOCOAGULATOR, MODEL MC-300 (K042785) | Nidek, Inc. | 2004-12-14 |
| NON-CONTACT TONOMETER, MODEL NT-4000 (K031733) | Nidek, Inc. | 2003-12-04 |
| GREEN LASER PHOTOCOAGULATOR MODEL GYC-1000 (K032085) | Nidek, Inc. | 2003-10-03 |
| NIDEK ADVANCED VISION INFORMATION SYSTEM (NAVIS) (K013694) | Nidek, Inc. | 2002-11-19 |
| ECHOSCAN, MODEL US-1800 (K020876) | Nidek, Inc. | 2002-05-03 |
| NON-MYDRIATIC FUNDUS CAMERA, MODEL NM-1000 (K014274) | Nidek, Inc. | 2002-04-17 |
| DC-3300 LASER DIODE PHOTOCOAGULATOR (K013760) | Nidek, Inc. | 2002-02-11 |