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Device | STAR S4 IR Excimer Laser System and iDesign Advanced WaveScan Studio System |
Generic Name | excimer laser system |
Applicant |
AMO Manufacturing USA, LLC |
510 cottonwood drive |
milpitas, CA 95035 |
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PMA Number | P930016 |
Supplement Number | S048 |
Date Received | 12/01/2016 |
Decision Date | 06/30/2017 |
Product Code |
LZS
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Docket Number | 17M-4022 |
Notice Date | 07/06/2017 |
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 STAR S4 IR Excimer Laser System and iDesign Advanced WaveScan Studio System. The STAR S4 IR Excimer Laser System and iDesign Advanced WaveScan Studio System is indicated for Wavefront-guided laser assisted in situ keratomileusis (LASIK) in patients: 1) with hyperopia with and without astigmatism as measured by iDesign® Advanced WaveScan Studio System up to +4.00 D spherical equivalent, with up to 2.00 D cylinder;2) with agreement between manifest refraction (adjusted for optical infinity) and iDesign® Advanced WaveScan Studio System refraction as follows: - Spherical Equivalent: Magnitude of the difference is less than 0.625 D. - Cylinder: Magnitude of the difference is less than or equal to 0.5 D;3) 18 years of age or older; and4) with refractive stability (a change of less than or equal to 1.0 D in sphere or cylinder for a minimum of 12 months 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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