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Device | LADARVISION 4000 EXCIMER LASER SYSTEM |
Generic Name | Excimer laser system |
Applicant | ALCON LABORATORIES 6201 S FREEWAY FT WORTH, TX 76134 |
PMA Number | P970043 |
Supplement Number | S020 |
Date Received | 05/27/2005 |
Decision Date | 05/01/2006 |
Withdrawal Date
|
05/15/2012 |
Product Code |
LZS |
Docket Number | 06M-0323 |
Notice Date | 08/17/2006 |
Advisory Committee |
Ophthalmic |
Supplement Type | Panel Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE LADARVISION 4000 EXCIMER LASER SYSTEM AND THE LADAR 6000 EXCIMER LASER SYSTEM. THESE DEVICES USE A 6.5 MM OPTICAL ZONE AND A 9.0 TREATMENT ZONE AND ARE INDICATED FOR WAVE-FRONT GUIDED CUSTOMCORNEA LASER ASSISTED IN-SITU KERATOMILEUSIS (LASIK): 1) FOR THE REDUCTION OR ELIMINATION OF HYPEROPIA AND HYPEROPIC ASTIGMATISM OF +0.75 D TO LESS THAT +5.00 D OF SPHERE WITH UP TO -3.00 D OF CYLINDER (WHICH HAS A MAGNITUDE LESS THAN OR EQUAL TO THE SPHERE IN MINUS CYLINDER CONVENTION) AND UP TO +5.00 CYCLOPLEGIC SPHERICAL EQUIVALENT AT THE SPECTACLE PLANE; 2) IN PATIENTS 21 YEARS OF AGE OR OLDER; AND 3) IN PATIENTS WITH DOCUMENTED STABILITY OF REFRACTION FOR THE PRIOR 12 MONTHS, AS DEMONSTRATED BY A CHANGE IN SPHERE AND CYLINDER OF LESS THAN OR EQUAL TO 0.50 D. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling Labeling Part 2 |