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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 NumberS009
Date Received11/23/2005
Decision Date10/11/2006
Product Code
LZS[ Registered Establishments with LZS ]
Docket Number 06M-0460
Notice Date 11/14/2006
Advisory Committee Ophthalmic
Supplement Typepanel track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR THE NIDEK EC-5000 EXCIMER LASER SYSTEM. THE DEVICE USES A 6.0 MM OPTICAL ZONE AND A 9.0 MM TREATMENT ZONE AND IS INDICATED FOR LASER ASSISTED IN-SITU KERATOMILEUSIS (LASIK): 1) FOR THE REDUCTION OR ELIMINATION OF HYPEROPIA REFRACTIVE ERRORS FROM +0.5 TO +5.0 D OF SPHERE WITH OR WITHOUT ASTIGMATIC REFRACTIVE ERRORS FROM +0.5 TO +2.0 D AT THE SPECTACLE PLANE WITH MANIFEST REFRACTION SPHERICAL EQUIVALENT (MRSE) OF +5.0 D OR LESS; 2) IN PATIENTS 21 YEARS OF AGE OR OLDER; AND 3) IN PATIENTS WITH DOCUMENTED STABILITY OF MANIFEST REFRACTION OVER THE PRIOR YEAR, DEMONSTRATED BY A CHANGE IN MRSE NOT GREATER THAN +/- 0.50 DIOPTER.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
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