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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceBAUSCH & LOMB TECHNOLAS T217Z ZYOPTIX LASER SYSTEM
Classification Nameexcimer laser system
Generic Nameexcimer laser system
Applicant
TECHNOLAS PERFECT VISION GMBH
messerschmittstr 1 + 3
munchen 80992
PMA NumberP990027
Supplement NumberS010
Date Received08/11/2008
Decision Date05/18/2010
Product Code
LZS[ Registered Establishments with LZS ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR THE FOLLOWING CHANGES: 1) REMOVAL OF A REDUNDANT FLUENCE TEST;2) INTRODUCTION OF A NEW SCANNER SYSTEM FROM GSI TO THE LASER SYSTEM:3) EXTRAPOLATION OF THE WAVEFRONT DATA IN THE DIAGNOSTIC ZYWAVE SOFTWARE;4) NEW ZRS (ZYOPTIX REMOTE SUPPORT) SOFTWARE TO MONITOR THE PERFORMANCE OF THELASER AND DIAGNOSTIC DEVICES REMOTELY VIA THE INTERNET;5) MODIFICATION OF THE ZRS TO INCLUDE TRULINK, AN ENHANCEMENT TO THE ZRS SYSTEM;6) INTRODUCTION OF A NEW OP FIELD ILLUMINATION IN THE LASER SYSTEM;7) CHANGE OF THE VIDEO CHIP IN THE CCD LENSLET CAMERA DMK4002-IR; AND8) CHANGE IN THE SUPPLIER OF THE TEMPERATURE CONTROL UNIT IN THE LASER SYSTEM.
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