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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
Classification Nameexcimer laser system
Generic Nameexcimer laser system
ApplicantBAUSCH & LOMB SURGICAL, INC.
PMA NumberP990027
Supplement NumberS009
Date Received12/19/2006
Decision Date02/01/2008
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 the expansion of the physician adjustment range for the spherical component rom +2. 5 d to -1. 0 d.
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