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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 443-0038
PMA NumberP970053
Supplement NumberS017
Date Received07/17/2017
Decision Date01/12/2018
Product Code LZS 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the change of laser head of the excimer laser, software upgrade to accommodate the laser head change, change of the PC and change to the power transformer.
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