LADARVISION 4000 EXCIMER LASER SYSTEM
FDA premarket approval P970043/S015 · decided 2004-06-29
Approval details
- PMA number
- P970043
- Supplement
- S015
- Supplement type
- Panel Track
- 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
- 2003-09-30
- Decision date
- 2004-06-29
- Days to decision
- 273 days
- Decision code
- APPR
- Product code
- LZS
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- APPROVAL FOR THE LADARVISION 4000 EXCIMER LASER SYSTEM. THE DEVICE USES A 6.5 MM OPTICAL ZONE, A 9.00 MM ABLATION ZONE, IS LOCKED-OUT FOR TREATMENTS ABOVE -9.75 DIOPTERS (D) SPHERE, -5.00D CYLINDER, AND -10.63D SPHERICAL EQUIVALENT (SE), AND IS INDICATED FOR WAVEFRONT-GUIDED LASER ASSISTED IN-SITU KERATOMILEUSIS (LASIK): 1) FOR THE REDUCTION OR ELIMINATION OF MYOPIC ASTIGMATISM UP TO -8.00D SPHERE WITH -0.50 TO -4.00D CYLINDER AND UP TO -8.00D SE AT THE SPECTACLE PLANE; 2) IN PATIENTS WHO ARE 21
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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 |