NEODYMIUM-YAG OP LASER OPL-3
FDA premarket approval P830064/S001 · decided 1985-02-06
Approval details
- PMA number
- P830064
- Supplement
- S001
- Trade name
- NEODYMIUM-YAG OP LASER OPL-3
- Generic name
- Laser, neodymium:Yag, ophthalmic for posterior capsulotomy and cutting pupilla
- Applicant
- Coburn Optical Ind., Inc.
- Date received
- 1984-10-11
- Decision date
- 1985-02-06
- Days to decision
- 118 days
- Decision code
- APPR
- Product code
- LXS
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Clearwater, FL
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| MAGNILINK SYSTEM 602 (K892351) | Coburn Optical Ind., Inc. | 1989-05-26 |
| MAGNILINK SYSTEM 101 (K892347) | Coburn Optical Ind., Inc. | 1989-05-26 |
| MAGNILINK SYSTEM 201 (K892348) | Coburn Optical Ind., Inc. | 1989-05-26 |
| MAGNILINK SYSTEM 402/5 (K892350) | Coburn Optical Ind., Inc. | 1989-05-26 |
| MAGNILINK SYSTEM 209 (K892349) | Coburn Optical Ind., Inc. | 1989-05-26 |
| IRRIGATION & ASPIRATION/VITRECTOMY DEVICE (K862188) | Coburn Optical Ind., Inc. | 1986-08-21 |
| COBURN I/A SYSTEM (K853457) | Coburn Optical Ind., Inc. | 1985-10-15 |
| DISP. MICROSURGICAL KNIVES (K821737) | Coburn Optical Ind., Inc. | 1982-07-02 |