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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 EXCIMER LASER SYSTEM EC-5000
Generic NameExcimer laser system
ApplicantNidek Co., Ltd.
34-14 Maehama
Hiroishi-Cho
Gamagori 443-0038
PMA NumberP970053
Supplement NumberS013
Date Received02/11/2014
Decision Date11/21/2014
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 TO USE THE OPD-SCAN III ABERROMETER AND UPDATE THE FINAL FIT SOFTWARE (V1.11 TO 1.12) TO FACILITATE COMPATIBILITY WITH A NEW ABERROMETER TO PERFORM TOPOGRAPHY-GUIDED LASER IN-SITU KERATOMILEUSIS (LASIK).
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