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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
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 NumberS002
Date Received04/19/1999
Decision Date04/14/2000
Product Code
LZS[ Registered Establishments with LZS ]
Docket Number 01M-0014
Notice Date 01/16/2001
Advisory Committee Ophthalmic
Supplement Typepanel track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? Yes
Combination Product No
Approval Order Statement 
INDICATIONS FOR USE OF THE NIDEK EC-5000 EXCIMER LASER SYSTEM.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
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