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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Microscope, Specular
510(k) Number K173980
Device Name Specular Microscope CEM-530
Applicant
Nidek Co., Ltd.
34-14 Maehama, Hiroishi-Cho
Gamagori,  JP 443-0038
Applicant Contact Yoneji Mizuno
Correspondent
Ora, Inc.
300 Brickstone Sq.
Andover,  MA  01810
Correspondent Contact Ryan Bouchard
Regulation Number886.1850
Classification Product Code
NQE  
Date Received12/29/2017
Decision Date 03/14/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Clinical Trials NCT02276638
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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