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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 | P020050 |
Date Received | 11/20/2002 |
Decision Date | 10/07/2003 |
Product Code |
LZS
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Docket Number | 03M-0491 |
Notice Date | 10/28/2003 |
Advisory Committee |
Ophthalmic |
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 AND 6.5 MM WITH AN ABLATION/TREATMENT ZONE UP TO 9.0 MM, AND S INDICATED FOR LASER ASSISTED IN SITU KERATOMILEUSIS (LASIK): 1) FOR THE REDUCTION OR ELIMINATION OF MYOPIA OF UP TO -12.0 DIOPTERS (D) OF SPHERE AND UP TO -6.0 D OF ASTIGMATISM AT THE SPECTACLE PLANE; 2) IN PATIENTS WHO ARE 18 YEARS OF AGE OR OLDER; AND 3) IN PATIENTS WITH DOCUMENTATION OF A STABLE MANIFEST REFRACTION DEFINED AS <=0.50D OF 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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Supplements: |
S026 S022 S016 S007 S001 S005 S003 S004 S002 S010 S017 S024 S023 S021 S018 S011 S009 S020 S015 S013 S019 S012 S008 S014 S006 S036 S031 S037 S035 S034 S033 S032 S028 S029 S027 S030 |