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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.
 
DeviceVISX STAR EXCIMER LASER SYSTEM
Generic NameExcimer laser system
ApplicantAMO Manufacturing USA, LLC
510 Cottonwood Drive
Milpitas, CA 95035
PMA NumberP930016
Supplement NumberS012
Date Received07/14/2000
Decision Date04/27/2001
Product Code LZS 
Docket Number 01M-0305
Notice Date 07/23/2001
Advisory Committee Ophthalmic
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? Yes
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE VISX STAR S2 AND S3 EXCIMER LASER SYSTEMS. THE DEVICES ARE INDICATED FOR LASER IN-SITU KERATOMILEUSIS (LASIK) TREATMENTS: 1) IN PATIENTS WITH DOCUMENTED EVIDENCE OF A CHANGE IN MANIFEST REFRACTION OF NO MORE THAN 0.5 D (IN BOTH CYLINDER AND SPHERE COMPONENTS) FOR AT LEAST ONE YEAR PRIOR TO THE DATE OF PRE-OPERATIVE EXAMINATION; AND 2) IN PATIENTS 21 YEARS OF AGE OR OLDER IN TREATMENTS FOR THE REDUCTION OF ELIMINATION OF NATURALLY OCCURRING HYPEROPIA BETWEEN +05 AND +5.0 D SPHERE AT THE SPECTACLE PLANE WITH OR WITHOUT REFRACTIVE ASTIGMATISM UP TO +3.0 D, WITH A MAXIMUM MANIFEST REFRACTION SPHERICAL EQUIVALENT (MRSE) OF +6.0 D.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
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