|
Device | LADARVISION EXCIMER LASER SYSTEM |
Generic Name | Excimer laser system |
Applicant | ALCON LABORATORIES 6201 S FREEWAY FT WORTH, TX 76134 |
PMA Number | P970043 |
Supplement Number | S009 |
Date Received | 08/04/2000 |
Decision Date | 08/28/2000 |
Withdrawal Date
|
05/15/2012 |
Product Code |
LZS |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR REDUCING BY 20% THE ABLATION DEPTH VALUES THAT ARE PROVIDED IN THE PHYSICIAN BOOKLET AND DISPLAYED BY THE DEVICE. |