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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Biomicroscope, Slit-Lamp, Ac-Powered
510(k) Number K161607
Device Name VISULUX
Applicant
CARL ZEISS MEDITEC AG
GOESCHWITZER STRASSE 54-52
JENA,  DE 07745
Applicant Contact Christian Muenster
Correspondent
CARL ZEISS MEDITEC AG
RUDOLF-EBER-STRASSE 11
Oberkochen,  DE 73447
Correspondent Contact Christian Muenster
Regulation Number886.1850
Classification Product Code
HJO  
Date Received06/10/2016
Decision Date 02/23/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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