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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 K230858
Device Name QUATERA 700
Applicant
Carl Zeiss Meditec, AG
Goeschwitzer Strasse 51-52
Jena,  DE 07745
Applicant Contact Hans-Joachim Miesner
Correspondent
Carl Zeiss Meditec, Inc.
5300 Central Pkwy.
Dublin,  CA  94568
Correspondent Contact Aditya Rao
Regulation Number886.4670
Classification Product Code
HQC  
Subsequent Product Code
HQE  
Date Received03/29/2023
Decision Date 07/31/2023
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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