VISULAS ND:YAG LASER
FDA premarket approval P850083/S004 · decided 1987-03-31
Approval details
- PMA number
- P850083
- Supplement
- S004
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- VISULAS ND:YAG LASER
- Generic name
- Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary
- Applicant
- Carl Zeiss, Inc.
- Date received
- 1986-11-14
- Decision date
- 1987-03-31
- Days to decision
- 137 days
- Decision code
- APPR
- Product code
- LOI
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Thornwood, NY
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| VISULAS 532S (K013402) | Carl Zeiss, Inc. | 2001-11-14 |
| VISULAS YAG II (K003885) | Carl Zeiss, Inc. | 2001-02-22 |
| IOLMASTER (K993357) | Carl Zeiss, Inc. | 2000-03-20 |
| OPMI TWINER SURGICAL MICROSCOPE (K983868) | Carl Zeiss, Inc. | 1999-01-29 |
| SURGICAL MICROSCOPE NAVIGATOR (SMN) SYSTEM/SURGICAL TOOL NAVIGATOR (STN) SYSTEM (K965139) | Carl Zeiss, Inc. | 1997-04-23 |
| CPC PROBE (K961380) | Carl Zeiss, Inc. | 1997-03-17 |
| HUMPHREY OCT SCANNER (K961171) | Carl Zeiss, Inc. | 1996-06-21 |
| HUMPHREY FIELD ANALYZER (HFA II) (K954167) | Carl Zeiss, Inc. | 1995-11-24 |