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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 |
PMA Number | P020050 |
Date Received | 11/20/2002 |
Decision Date | 10/07/2003 |
Product Code |
LZS |
Docket Number | 03M-0491 |
Notice Date | 10/28/2003 |
Advisory Committee |
Ophthalmic |
Expedited Review Granted? | No |
Combination Product | No |
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 |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling Labeling Part 2 |
Supplements: |
S017 S006 S012 S013 S019 S010 S008 S007 S002 S004 S026 S015 S016 S023 S024 S011 S020 S021 S009 S018 S022 S014 S003 S001 S005 S029 S039 S036 S037 S042 S030 S028 S027 S031 S032 S034 S035 S033 S041 S040 S038 |