CILCO ND:YAG LASER
FDA premarket approval P840047/S002 · decided 1987-01-09
Approval details
- PMA number
- P840047
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- CILCO ND:YAG LASER
- Generic name
- Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary
- Applicant
- Coopervision-Cilco
- Date received
- 1986-11-28
- Decision date
- 1987-01-09
- Days to decision
- 42 days
- Decision code
- APPR
- Product code
- LOI
- Advisory committee
- Ophthalmic
- Expedited review
- No
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| KRATZ NOVA SERT(TM) (K883489) | Coopervision-Cilco | 1988-10-25 |
| CILCO VILLASENOR PACHYMETER (K882805) | Coopervision-Cilco | 1988-08-12 |