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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 EX500 EXCIMER LASER SYSTEM
Generic NameExcimer laser system
ApplicantAlcon Laboratories, Inc.
6201 S. Fwy.
Fort Worth, TX 76134
PMA NumberP020050
Supplement NumberS015
Date Received01/22/2014
Decision Date04/10/2014
Product Code LZS 
Advisory Committee Ophthalmic
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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