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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.
 
DeviceNIDEK EC-5000 EXCIMER LASER SYSTEM
Generic NameExcimer laser system
ApplicantNIDEK CO., LTD.
34-14 MAEHAMA, HIROISHI-CHO
GAMAGORI, AICHI 443-0-0038
PMA NumberP970053
Supplement NumberS002
Date Received04/19/1999
Decision Date04/14/2000
Product Code LZS 
Docket Number 01M-0014
Notice Date 01/16/2001
Advisory Committee Ophthalmic
Supplement TypePanel Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? Yes
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
INDICATIONS FOR USE OF THE NIDEK EC-5000 EXCIMER LASER SYSTEM.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
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