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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 Nameophthalmic medical laser system (193 nanometer wavelength)
ApplicantALCON LABORATORIES, INC.
PMA NumberP030008
Supplement NumberS012
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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