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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
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