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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.
 
DeviceEC-5000 EXCIMER LASER SYSTEM
Generic NameExcimer laser system
ApplicantNidek Co., Ltd.
34-14 Maehama
Hiroishi-Cho
Gamagori 443-0038
PMA NumberP970053
Supplement NumberS003
Date Received04/28/2000
Decision Date10/25/2000
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 INCORPORATION OF THE NOMOGRAM FOR LASER IN-SITU KERATOMILEUSIS (LASIK) TREATMENTS INTO THE NIDEK EC-5000 SOFTWARE, ALONG WITH THE NOMOGRAM FOR PRK FOR MODERATE MYOPIA WITH ASTIGMATISM.
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