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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 NumberS012
Date Received09/25/2012
Decision Date12/12/2012
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 REPLACEMENT OF THE LASER DIODE FOR THE AIMING BEAM, THECORRESPONDING MODIFICATION OF THE AIMING BEAM OPTICAL SYSTEM, AND ASSOCIATED LABELING CHANGES.
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