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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
Classification Nameexcimer laser system
Generic Nameexcimer laser system
ApplicantTECHNOLAS GMBH PERFECT VISION
PMA NumberP990027
Supplement NumberS013
Date Received10/01/2009
Decision Date11/04/2009
Product Code
LZS[ Registered Establishments with LZS ]
Advisory Committee Ophthalmic
Supplement Typereal-time process
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for software changes introduced in software version 4. 23a that affected the error message displays during the conditioning, energy verification, and treatment phases. The device, as modified, will be marketed under the trade name technolas t217z zyoptix laser system for personalized vision correction and is indicated for wavefront-guided laser assisted in-situ keratomileusis (lasik) treatments for the reduction or elimination of myopia with sphere up to -7. 00d and cylinder up to -3. 00d and mrse <=7. 50d at the spectacle plane.
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