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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 NameBAUSCH & LOMB TECHNOLAS 217Z ZYOPTIX SYSTEM FOR PERSONALIZED VISION CORRECTION
Classification Nameexcimer laser system
Generic Nameexcimer laser system
ApplicantBAUSCH & LOMB TECHNOLAS GMBH
PMA NumberP990027
Supplement NumberS012
Date Received05/26/2009
Decision Date06/26/2009
Product Code
LZS[ Registered Establishments with LZS ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track no user fee
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a manufacturing site change located at technolas perfectvision gmbh, munich, germany.
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