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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.
 
DeviceWAVELIGHT EX500 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 NumberS013
Date Received01/22/2014
Decision Date04/10/2014
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 AN ALTERNATE MODIFIED PATIENT SWIVEL BED FOR USE WITH THE WAVELIGHT® EX500 EXCIMER LASER SYSTEM. THE MODIFICATIONS ALLOW THE PATIENT BED TO BE USED WITH FEMTOSECOND LASERS OTHER THAN THE WAVELIGHT FS200 LASER TO CREATE THE FLAP FOR LASER-ASSISTED IN SITU KERATOMILEUSIS (LASIK).
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