PMA P970043
- Device
- LADARVISION 4000 AND LADAR6000 EXCIMER LASER SYSTEMS AND THE CUSTOMCORNEA SURGERY PLANNING SOFTWARE
- Applicant
- Alcon Laboratories
- PMA number
- P970043
- Supplement
- S007
- Product code
- LZS
- Decision date
- 2006-11-01
- Generic name
- Excimer laser system
- Approval order statement
- APPROVAL FOR A SOFTWARE CHANGE TO THE WAVEFRONT-IMAGE GATHERING SEQUENCE IN THE CUSTOMCORNEA SURGERY PLANNING SOFTWARE TO ALLOW FOR DIFFERENT PRE-OP AND SURGERY DAYS; A CHANGE TO THE LADAR6000 SOFTWARE TO ALLOW FOR CONVENTIONAL CENTRATION PHOTOS TO BE IMPORTED FROM THE LADARWAVE CUSTOMCORNEA WAVEFRONT SYSTEM; AND, MINOR ENHANCEMENTS/BUG FIXES TO THE LADARVISION 4000 SOFTWARE, THE LADAR6000 SYSTEM SOFTWARE, AND THE CUSTOMCORNEA SURGERY PLANNING SOFTWARE.
Current openFDA PMA Record
- Device
- LADARVISION 4000 AND LADAR6000 EXCIMER LASER SYSTEMS AND THE CUSTOMCORNEA SURGERY PLANNING SOFTWARE
- Applicant
- Alcon Laboratories
- PMA number
- P970043
- Supplement
- S026
- Product code
- LZS
- Generic name
- Excimer laser system
- Decision date
- 2006-11-01
- Decision code
- APPR
- Date received
- 2006-09-28
- Supplement type
- Real-Time Process
- Approval order statement
- APPROVAL FOR A SOFTWARE CHANGE TO THE WAVEFRONT-IMAGE GATHERING SEQUENCE IN THE CUSTOMCORNEA SURGERY PLANNING SOFTWARE TO ALLOW FOR DIFFERENT PRE-OP AND SURGERY DAYS; A CHANGE TO THE LADAR6000 SOFTWARE TO ALLOW FOR CONVENTIONAL CENTRATION PHOTOS TO BE IMPORTED FROM THE LADARWAVE CUSTOMCORNEA WAVEFRONT SYSTEM; AND, MINOR ENHANCEMENTS/BUG FIXES TO THE LADARVISION 4000 SOFTWARE, THE LADAR6000 SYSTEM SOFTWARE, AND THE CUSTOMCORNEA SURGERY PLANNING SOFTWARE.