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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 EX 500 LASER SYSTEM
Classification Nameexcimer laser system
Generic Nameophthalmic medical laser system (193 nanometer wavelength)
ApplicantALCON LABORATORIES, INC.
PMA NumberP030008
Supplement NumberS010
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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