PICOLAS NEODYMIUN-YAG OPHTHALMIC LASEER
FDA premarket approval P830080 · decided 1987-02-17
Approval details
- PMA number
- P830080
- Trade name
- PICOLAS NEODYMIUN-YAG OPHTHALMIC LASEER
- Generic name
- Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary
- Applicant
- Synemed, Inc.
- Date received
- 1983-12-30
- Decision date
- 1987-02-17
- Days to decision
- 1145 days
- Decision code
- APPR
- Product code
- LOI
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Berkeley, CA
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| FIELD TREND (K954037) | Synemed, Inc. | 1995-11-17 |
| THE FIELDMASTER MODEL 275 (K852936) | Synemed, Inc. | 1985-10-15 |
| DERMATOLOGY HANDPIECE-OPHTH LASER (K833274) | Synemed, Inc. | 1983-12-03 |
| SYNEVAC VACUUM SOURCE UNIT (K831085) | Synemed, Inc. | 1983-06-08 |
| OPTHALAS PHOTOCOAGULATOR (K828585) | Synemed, Inc. | 1983-01-03 |
| MODEL 200 SQUID (K822853) | Synemed, Inc. | 1982-10-18 |
| SYNEVAC VACUUM CURETTAGE SYSTEMS (K813282) | Synemed, Inc. | 1981-12-14 |
| SCOPE MASTER (K811270) | Synemed, Inc. | 1981-09-08 |