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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 NameWAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM
Classification Nameexcimer laser system
Generic Nameexcimer laser system
ApplicantALCON LABORATORIES, INC.
PMA NumberP020050
Supplement NumberS014
Date Received07/22/2013
Decision Date10/18/2013
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 the wavenet¿ planning software (wps), a stand-alone user interface software system for the wavelight® ex500 excimer laser system. The wps enables the physician to plan surgical cases remotely in advance of the planned surgical date.
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