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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.
 
Trade NameVISX STAR S2 EXCIMER LASER SYSTEM
Classification Nameexcimer laser system
Generic Nameeximer laser for ophthalmic use
ApplicantVISX, INCORPORATED
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
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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
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