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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 NumberS006
Date Received03/15/2001
Decision Date09/04/2001
Product Code LZS 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL TO MODIFY THE APPROVED CLAIM FOR THE EC-5000 EXCIMER LASER SYSTEM TO ALLOW FOR THREATMENTS USING AN OPTICAL ZONE SIZE OF 5.5 MM TO 6.5 MM, IN ADDITION TO THE APPROVED OPTICAL ZONE SIZE OF T.T MM, FOR LASIK TREATMENT OF MYOPIA AND MYOPIA WITH ASTIGMATISM. THE DEVICE, AS MODIFIED, WILL CONTINUE TO BE MARKETED UNDER THE TRADE NAME NIDEK EC-5000 EXCIMER LASER SYSTEM AND REMAINS INDICATED FOR THE REDUCTION OR ELIMINATION OF -1.00 D TO -14.00 D MYOPIA SPHERICAL EQUIVALENT WITH OR WITHOUT <=-4 D ASTIGMATISM.
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