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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.
 
DeviceIDESIGN ADVANCED WAVESCAN STUDIO, STAR EXCIMER LASER SYSTEM
Generic NameExcimer laser system
ApplicantAMO Manufacturing USA, LLC
510 Cottonwood Drive
Milpitas, CA 95035
PMA NumberP930016
Supplement NumberS045
Date Received06/01/2015
Decision Date11/14/2016
Product Code LZS 
Docket Number 16M-3915
Notice Date 12/14/2016
Advisory Committee Ophthalmic
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the STAR S4 IR Excimer Laser System and iDesign Advanced WaveScan Studio Indication System is indicated for wavefront-guided laser assisted in situ keratomileusis (LASIK) for Use: in patients:1) with mixed astigmatism as measured by iDesign Advanced WaveScan Studio System where the magnitude of cylinder (1.0 to 5.0 D) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs; 2) with agreement between manifest refraction (adjusted for optical infinity) and iDesign Advanced WaveScan Studio System refraction as follows:a) Spherical Equivalent: Magnitude of the difference is less than 0.625 D; b)Cylinder: Magnitude of the difference is less than or equal to 0.5 D.; and c) 18 years of age or older, and 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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