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Device | WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM |
Generic Name | excimer laser system |
Applicant |
Alcon Laboratories, Inc. |
6201 south freeway |
fort worth, TX 76134-2099 |
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PMA Number | P030008 |
Supplement Number | S004 |
Date Received | 10/24/2005 |
Decision Date | 04/19/2006 |
Product Code |
LZS
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Docket Number | 06M-0199 |
Notice Date | 05/12/2006 |
Advisory Committee |
Ophthalmic |
Supplement Type | panel track |
Supplement Reason | labeling change - indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product |
No
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Approval Order Statement
APPROVAL FOR THE WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM. THE DEVICE USED OPTICAL ZONES OF 6.0-7.0 MM WITH AN ABLATION/TREATMENT ZONE UP TO 9.0 MM, AND IS INDICATED FOR LASER ASSISTED IN SITU KERATOMILEUSIS (LASIK) FOR: 1) THE REDUCTION OR ELIMINATION OF NATURALLY OCCURRING MIXED ASTIGMATISM OF UP TO 6.00 DIOPTERS (D) AT THE SPECTACLE PLANE; 2) PATIENTS WHO ARE 21 YEARS OF AGE OR OLDER; AND 3) PATIENTS WITH DOCUMENTATION OF A STABLE MANIFEST REFRACTION DEFINED AS <= 0.50 D PREOPERATIVE SPHERICAL EQUIVALENT SHIFT OVER ONE YEAR PRIOR TO SURGERY. |
Approval Order |
Approval Order
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Summary |
Summary of Safety and Effectiveness |
Labeling |
Labeling
Labeling Part 2
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