LADAR VISION EXCIMER LASER SYSTEM (HYPEROPIA)
FDA premarket approval P970043/S007 · decided 2000-09-22
Approval details
- PMA number
- P970043
- Supplement
- S007
- Supplement type
- Panel Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- LADAR VISION EXCIMER LASER SYSTEM (HYPEROPIA)
- Generic name
- Excimer laser system
- Applicant
- Alcon Laboratories
- Date received
- 1999-09-03
- Decision date
- 2000-09-22
- Days to decision
- 385 days
- Decision code
- APPR
- Product code
- LZS
- Advisory committee
- Ophthalmic
- Expedited review
- Yes
- Location
- Fort Worth, TX
- Statement
- APPROVAL FOR THE LADARVISION(R) EXCIMER LASER SYSTEM. THE DEVICE IS INDICATED FOR LASER IN-SITU KERATOMILEUSIS (LASIK) TREATMENTS: 1) FOR THE REDUCTION OR ELIMINATINO OF REFRACTIVE ERROR OF LESS THAN OR EQUAL TO +6.00D OF SPHERE AND -6.00D OF CYLINDER AT THE SPECTACLE PLANE (HYPEROPIA WITH OR WITHOUT ASTIGMATISM AND MIXED ASTIGMATISM); 1) IN SUBJECTS WITH DOCUMENTED STABILITY OF REFRACTION FOR THE PRIOR 12 MONTHS, AS DEMONSTRATED BY A CHANGE OF LESS THAN OR EQUAL TO 0.50D FOR CORRECTIONS UP TO +
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
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 |