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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
DeviceVISX STAR S2 EXCIMER LASER SYSTEM
Classification Nameexcimer laser system
Generic Nameexcimer laser system
Applicant
AMO Manufacturing USA, LLC
510 cottonwood drive
milpitas, CA 95035
PMA NumberP930016
Supplement NumberS007
Date Received03/05/1998
Decision Date11/02/1998
Product Code
LZS[ Registered Establishments with LZS ]
Docket Number 00M-1391
Notice Date 07/14/2000
Advisory Committee Ophthalmic
Supplement Typepanel track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the visx excimer laser system. This device is indicated for hyperopic prk using an ablation zone with a correction diameter of 5. 0 mm and an overall diameter of 9. 0mm.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
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