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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceSTAR S4 IR Excimer Laser System and iDesign Advanced WaveScan Studio System
Generic NameExcimer laser system
ApplicantAMO Manufacturing USA, LLC
510 Cottonwood Drive
Milpitas, CA 95035
PMA NumberP930016
Supplement NumberS048
Date Received12/01/2016
Decision Date06/30/2017
Product Code LZS 
Docket Number 17M-4022
Notice Date 07/06/2017
Advisory Committee Ophthalmic
Clinical TrialsNCT01675479
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
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