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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.
Classification Nameexcimer laser system
Generic Nameexcimer laser system
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.