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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
Classification Nameexcimer laser system
Generic Nameexcimer laser system
Applicant
NIDEK CO., LTD.
34-14 maehama, hiroishi-cho
gamagori, aichi 443-0-0038
PMA NumberP970053
Supplement NumberS010
Date Received08/08/2006
Decision Date11/08/2006
Product Code
LZS[ Registered Establishments with LZS ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR MODIFICATIONS TO THE NIDEK EC-5000 EXCIMER LASER SYSTEM (MODEL CXII) INCLUDING A REDUCTION IN SIZE, THE STANDARDIZATION OF PREVIOUSLY OPTIONAL FEATURES, INCORPORATING THE CONTROL COMPUTER INTO THE COMPUTER (PREVIOUSLY STAND-ALONE) AND REPLACING THE ORIGINAL (MANUAL MAGNIFICATION) MICROSCOPE WITH A NEW MODEL WITH MOTORIZED MAGNIFICATION CONTROL. THE NEW DEVICE WILL BE NAMED THE NIDEK EC-5000 EXCIMER LASER SYSTEM MODEL CXIII.
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