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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Phacofragmentation
510(k) Number K193376
Device Name Visalis V500, Visalis S500
Applicant
Carl Zeiss Meditec, AG
Goeschwitzer Strasse 51-52
Jena,  DE 07745
Applicant Contact Katrin Faber
Correspondent
Carl Zeiss Meditec, AG
Goeschwitzer Strasse 51-52
Jena,  DE 07745
Correspondent Contact Katrin Faber
Regulation Number886.4670
Classification Product Code
HQC  
Date Received12/05/2019
Decision Date 06/15/2020
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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