LADARVISION 4000 EXCIMER LASER SYSTEM
FDA premarket approval P970043/S013 · decided 2003-07-16
Approval details
- PMA number
- P970043
- Supplement
- S013
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- LADARVISION 4000 EXCIMER LASER SYSTEM
- Generic name
- Excimer laser system
- Applicant
- Alcon Laboratories
- Date received
- 2003-07-02
- Decision date
- 2003-07-16
- Days to decision
- 14 days
- Decision code
- APPR
- Product code
- LZS
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- APPROVAL FOR AN EXPANSION OF +- 0.75 D FOR THE ALLOWABLE TARGET OFFSET PARAMETER RANGE FOR THE WAVEFRONT-GUIDED MYOPIC LASIK INDICATION. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME LADARVISION 4000 EXCIMER LASER SYSTEM AND IS INDICATED FOR THE REDUCTION OR ELIMINATION OF MYOPIA UP TO -7.00 D WITH LESS THAN -0.50 D OF ASTIGMATISM AT THE SPECTACLE PLANE.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| NEXT GENERATION LASER (K062624) | Alcon Laboratories | 2007-11-05 |
| SMALL VOLUME SYRINGE (K062865) | Alcon Laboratories | 2007-08-23 |
| RGP MULTI-PURPOSE SOLUTION ID 100136 (K000148) | Alcon Laboratories | 2000-04-11 |
| OPTI-FREE EXPRESS MULTI-ACTION CLEANING AND REWETTING DROP (K984573) | Alcon Laboratories | 1999-09-16 |
| OPTI-FREE SUPRACLENS DAILY PROTEIN REMOVER (K990480) | Alcon Laboratories | 1999-05-10 |
| MULTI-PURPOSE DISINFECTING SOLUTION ID 90746 (K984575) | Alcon Laboratories | 1999-01-14 |
| OPTI-ONE MULTI-PURPOSE SOLUTION (K983973) | Alcon Laboratories | 1998-12-18 |
| MULTI-PURPOSE DISINFECTING SOLUTION ID 90746 (K983780) | Alcon Laboratories | 1998-12-18 |