NEODYMIUM: YAG OPHTHALMIC LASER SYSTEM 9900
FDA premarket approval P830054/S013 · decided 1986-10-15
Approval details
- PMA number
- P830054
- Supplement
- S013
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- NEODYMIUM: YAG OPHTHALMIC LASER SYSTEM 9900
- Generic name
- Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary
- Applicant
- Coherent Medical Division
- Date received
- 1986-09-08
- Decision date
- 1986-10-15
- Days to decision
- 37 days
- Decision code
- APPR
- Product code
- LOI
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Palo Alto, CA
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| COHERENT HOLMIUM:YAG SURGICAL LASER (K902990) | Coherent Medical Division | 1990-10-02 |
| COHERENT FUNDUSL RETINAL CAMERA (K822908) | Coherent Medical Division | 1983-01-05 |
| THE OCUPLOT D (K822415) | Coherent Medical Division | 1982-09-07 |
| DIOPTRON III AUTOREFRACTOR (K801906) | Coherent Medical Division | 1980-08-27 |
| MODEL 900K PHOTOCOAGULATOR (K801336) | Coherent Medical Division | 1980-07-28 |
| ACCESSORIES FOR SYS. 400 CO2 SURG. LASER (K791895) | Coherent Medical Division | 1979-12-20 |