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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 NameTECHNOLAS 217A EXCIMER LASER SYSTEM AND TECHNOLAS 217Z ZYOPTIX SYSTEM
Classification Nameexcimer laser system
Generic Nameexcimer laser system
ApplicantTECHNOLAS GMBH PERFECT VISION
PMA NumberP990027
Supplement NumberS017
Date Received04/26/2012
Decision Date01/18/2013
Product Code
LZS[ Registered Establishments with LZS ]
Advisory Committee Ophthalmic
Supplement Typereal-time process
Supplement Reason process change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an alternate source to produce the thyratron power supply and laser head assemblies.
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