Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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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 | S015 |
Date Received | 09/30/2003 |
Decision Date | 06/29/2004 |
Withdrawal Date
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05/15/2012 |
Product Code |
LZS |
Docket Number | 04M-0312 |
Notice Date | 07/16/2004 |
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. THE DEVICE USES A 6.5 MM OPTICAL ZONE, A 9.00 MM ABLATION ZONE, IS LOCKED-OUT FOR TREATMENTS ABOVE -9.75 DIOPTERS (D) SPHERE, -5.00D CYLINDER, AND -10.63D SPHERICAL EQUIVALENT (SE), AND IS INDICATED FOR WAVEFRONT-GUIDED LASER ASSISTED IN-SITU KERATOMILEUSIS (LASIK): 1) FOR THE REDUCTION OR ELIMINATION OF MYOPIC ASTIGMATISM UP TO -8.00D SPHERE WITH -0.50 TO -4.00D CYLINDER AND UP TO -8.00D SE AT THE SPECTACLE PLANE; 2) IN PATIENTS WHO ARE 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 0.50D FOR A SE OF UP TO -6.00D AND LESS THAN OR EQUAL TO 0.75D FOR A SE GREATER THAN -6.00D. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
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