| 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 |
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| Generic Name | Excimer laser system |
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| Applicant | ALCON LABORATORIES
6201 S FREEWAY
FT WORTH, TX 76134 |
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| PMA Number | P970043 |
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| Supplement Number | S015 |
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| Date Received | 09/30/2003 |
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| Decision Date | 06/29/2004 |
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Withdrawal Date
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05/15/2012 |
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| Product Code |
LZS |
| Docket Number | 04M-0312 |
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| Notice Date | 07/16/2004 |
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| Advisory Committee |
Ophthalmic |
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| Supplement Type | Panel Track |
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| Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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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 |
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| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
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