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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 S4 IR EXCIMER LASER SYSTEM AND WAVESCAN SYSTEM
Classification Nameexcimer laser system
Generic Nameexcimer laser for ophthalmic use
ApplicantVISX, INCORPORATED
PMA NumberP930016
Supplement NumberS026
Date Received10/25/2006
Decision Date11/03/2006
Product Code
LZS[ Registered Establishments with LZS ]
Advisory Committee Ophthalmic
Supplement Typereal-time process
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an upgrade of the wavescan software to version 3. 67 to correct a design flaw that led to an incorrect patient treatment being delivered, and to introduce an additional software check to mitigate treatment calculation errors.
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