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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceWAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM
Classification Nameexcimer laser system
Generic Nameexcimer laser system
Applicant
Alcon Laboratories, Inc.
6201 south freeway
fort worth, TX 76134-2099
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/material
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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