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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 & STAR S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS)
Classification Nameexcimer laser system
Generic Nameexcimer laser for ophthalmic use
ApplicantAMO MANUFACTURING USA, LLC
PMA NumberP930016
Supplement NumberS032
Date Received09/18/2009
Decision Date03/09/2010
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 version 4. 70 (star s4) and version 5. 30 (star s4 ir).
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