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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 EX500 LASER SYSTEM, ALLEGRO ANALYZER
Classification Nameexcimer laser system
Generic Nameexcimer laser system
ApplicantALCON LABORATORIES, INC.
PMA NumberP020050
Supplement NumberS011
Date Received01/18/2013
Decision Date04/12/2013
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 to introduce the wavenet¿ network system to facilitate data exchange between fda approved/ cleared wavelight® refractive/ therapeutic and diagnostic devices via a network server.
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