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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 2000 EC-5000 EXCIMER LASER SYSTEM
Generic NameExcimer laser system
ApplicantNidek Co., Ltd.
34-14 Maehama
Hiroishi-Cho
Gamagori 443-0-0038
PMA NumberP970053
Supplement NumberS011
Date Received03/30/2007
Decision Date09/30/2013
Product Code LZS 
Docket Number 13M-1362
Notice Date 10/30/2013
Advisory Committee Ophthalmic
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE NIDEK EC-5000 EXCIMER LASER SYSTEM. THIS DEVICE IS INDICATED FOR TOPOGRAPHY-ASSISTED LASER- ASSISTED IN-SITU KERATOMILEUSIS (LASIK) TREATMENT USING THE FINAL FIT¿ CUSTOM ABLATION TREATMENT PLANNING SOFTWARE FOR THE REDUCTION OR ELIMINATION OF MYOPIC REFRACTIVE ERRORS FROM -1.0 TO -4.0 D OF SPHERE WITH ASTIGMATIC REFRACTIVE ERRORS FROM >-0.5 TO -2.0 D AT THE SPECTACLE PLANE; IN PATIENTS 21 YEARS OF AGE OR OLDER; AND, IN PATIENTS WITH DOCUMENTED STABILITY OF MANIFEST REFRACTION OVER THE PRIOR YEAR, DEMONSTRATED BY A CHANGE IN MRSE NOT GREATER THAN ±0.5 D.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
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