ALCON LADARVISION 4000 EXCIMER LASER SYSTEM-
FDA premarket approval P970043/S021 · decided 2005-10-14
Approval details
- PMA number
- P970043
- Supplement
- S021
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ALCON LADARVISION 4000 EXCIMER LASER SYSTEM-
- Generic name
- Excimer laser system
- Applicant
- Alcon Laboratories
- Date received
- 2005-09-26
- Decision date
- 2005-10-14
- Days to decision
- 18 days
- Decision code
- APPR
- Product code
- LZS
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- APPROVAL FOR A SOFTWARE CALIBRATION "LOCK-OUT" FEATURE WHERBY THE LASER SYSTEM WILL BE "LOCKED-OUT" TO PREVENT THE INITIATION OF SURGERY MORE THAN 60 MINUTES AFTER THE LAST SYSTEM CALIBRATION, A "COUNTDOWN CLOCK" ON THE COMPUTER MONITOR WHICH WILL PROVIDE THE USER WITH FEEDBACK ON THE REMAINING TIME BEFORE THE SYSTEM WILL LOCK-OUT, AND A SOFTWARE BUG FIX TO CORRECT A CERTAIN "BUG" FROM OCCURRING UNDER CERTAIN CONDITIONS IF THE RULER TOOL WAS USED WITH THE TRACKER ENGAGED DURING SURGERY.
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 |