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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 WITH IDESIGN WAVESCAN STUDIO SYSTEM
Generic NameExcimer laser system
ApplicantAMO Manufacturing USA, LLC
510 Cottonwood Drive
Milpitas, CA 95035
PMA NumberP930016
Supplement NumberS044
Date Received11/10/2014
Decision Date05/06/2015
Product Code LZS 
Docket Number 15M-1707
Notice Date 07/15/2015
Advisory Committee Ophthalmic
Clinical TrialsNCT01663363
Supplement TypePanel Track
Supplement Reason Change Design/Components/Specifications/Material
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. THIS DEVICE USES A 6.0 MM OPTICAL ZONE, AND 8.0 MM TREATMENT ZONE, AND IS INDICATED FOR WAVEFRONT-GUIDED (WFG) LASER ASSISTED IN SITU KERATOMILEUSIS (LASIK) IN PATIENTS:1) WITH MYOPIA AS MEASURED BY THE IDESIGN ADVANCED WAVESCAN STUDIO SYSTEM UP TO -11 D SPHERICAL EQUIVALENT WITH UP TO -5 D CYLINDER; AND2) WITH AGREEMENT BETWEEN MANIFEST REFRACTION (ADJUSTED FOR OPTICAL INFINITY) AND IDESIGN ADVANCED WAVESCAN STUDIO SYSTEM REFRACTION AS FOLLOWS:1) SPHERICAL EQUIVALENT: MAGNITUDE OF THE DIFFERENCE IS LESS THAN 0.625 D; AND 2) CYLINDER: MAGNITUDE OF THE DIFFERENCE IS LESS THAN OR EQUAL TO 0.5 D; A) 18 YEARS OF AGE OR OLDER; AND B) WITH REFRACTIVE STABILITY (A CHANGE OF ¿ 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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