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Device | STAR S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS) |
Generic Name | excimer laser system |
Applicant |
AMO Manufacturing USA, LLC |
510 cottonwood drive |
milpitas, CA 95035 |
|
PMA Number | P930016 |
Supplement Number | S020 |
Date Received | 09/21/2004 |
Decision Date | 03/17/2005 |
Product Code |
LZS
|
Docket Number | 05M-0151 |
Notice Date | 04/19/2005 |
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 VISX STAR S4 IR EXCIMER LASER SYSTEM WITH VSS AND WAVESCAN WAVEFRONT SYSTEM. THE DEVICE USES A 6.0 MM OPTICAL ZONE, A 9.0 MM TREATMENT ZONE, AND IS INDICATED FOR WAVEFRONT-GUIDED LASER ASSISTED IN SITU KERATOMILEUSIS (LASIK): 1) FOR THE REDUCTION OR EE AND THE CYLINDER AND SPHERE HAVE OPPOSITE SIGNS; 2) IN PATIENTS 21 YEARS OF ATH CYLINDER AND SPHERE COMPONENTS) FOR AT LEAST ONE YEAR PRIOR TO THE DATE OF PRE-OPERATIVE EXAMINATION. |
Approval Order |
Approval Order
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Summary |
Summary of Safety and Effectiveness |
Labeling |
Labeling
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