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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 ACTIVETRAK EXCIMER LASER SYSTEM AND WAVESCAN WAVEFRONT SYSTEM
Classification Nameexcimer laser system
Generic Nameexcimer laser for ophthalmic use
ApplicantVISX, INCORPORATED
PMA NumberP930016
Supplement NumberS018
Date Received12/16/2003
Decision Date06/07/2004
Product Code
LZS[ Registered Establishments with LZS ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for software upgrade: wavescan software version 3. 5 changes from currently approved version 3. 07 (under p930016/s016) for visx star s4 activetrak excimer laser system for wavefront-guided lasik treatments of myopic astigmatism up to -6. 00 d mrse, with cylinder between 0. 00 and -3. 00 d.
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