|
Device | LADAR VISION 4000 EXCIMER LASER SYSTEM |
Generic Name | Excimer laser system |
Applicant | ALCON LABORATORIES 6201 S FREEWAY FT WORTH, TX 76134 |
PMA Number | P970043 |
Supplement Number | S016 |
Date Received | 11/10/2003 |
Decision Date | 02/09/2004 |
Withdrawal Date
|
05/15/2012 |
Product Code |
LZS |
Advisory Committee |
Ophthalmic |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A NEW LASER ASSEMBLY SYSTEM TO REPLACE THE EXISTING ASSEMBLY IN THE APPROVED LADARVISION 4000 EXCIMER LASER SYSTEM. |