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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 NameSTAR S4 IR EXCIMER LASER SOFTWARE, VERSION 5.10
Classification Nameexcimer laser system
Generic Nameexcimer laser for ophthalmic use
ApplicantVISX, INCORPORATED
PMA NumberP930016
Supplement NumberS022
Date Received03/30/2005
Decision Date05/02/2005
Product Code
LZS[ Registered Establishments with LZS ]
Advisory Committee Ophthalmic
Supplement Typereal-time process
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for software and labeling changes regarding the iris registration functionality of the device.
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