LADAR 6000 EXCIMER LASER SYSTEM
FDA premarket approval P970043/S019 · decided 2006-05-01
Approval details
- PMA number
- P970043
- Supplement
- S019
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- LADAR 6000 EXCIMER LASER SYSTEM
- Generic name
- Excimer laser system
- Applicant
- Alcon Laboratories
- Date received
- 2004-11-30
- Decision date
- 2006-05-01
- Days to decision
- 517 days
- Decision code
- APPR
- Product code
- LZS
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- APPROVAL FOR CHANGES IN THE LADARVISION 4000 SYSTEM INCLUDING A NEW CONFIGURATION OF THE ILLUMINATION SYSTEM, UPGRADES TO THE LASER COMPUTER AND OPERATING SYSTEM, AND VARIOUS OTHER HARDWARE AND SOFTWARE CHANGES INTENDED TO ADDRESS COMPLIANCE WITH EMI REQUIREMENTS, MANAGE COMPONENT OBSOLESCENCE, REDUCE MAINTENANCE REQUIREMENTS, AND ENHANCE ERGONOMIC AND USER INTERFACE FEATURES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME LADAR 6000 EXCIMER LASER SYSTEM.
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 |