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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
Classification Nameexcimer laser system
Generic Nameophthalmic medical laser system (193 nanometer wavelength)
ApplicantALCON LABORATORIES, INC.
PMA NumberP030008
Supplement NumberS019
Date Received03/04/2015
Decision Date06/02/2015
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 a new software release for the wavelight® ex500 excimer laser system (model 1016-3), wavenet¿ planning software (wps) - standalone software. (model 6164), and allegro topolyzer vario - topographer (model 1028) the devices, as modified, will continue to be marketed under the trade names wavelight® ex500 excimer laser system - excimer laser system (model 1016-3), wavenet¿ planning software (wps) - standalone software. (model 6164), and allegro topolyzer vario - topographer (model 1028).
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