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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 K253834
Device Name VISUREF 600
Applicant
Carl Zeiss Vision GmbH
Turnstrasse 27
Aalen,  DE 73430
Applicant Contact Oliver Jucha-Schade
Correspondent
Carl Zeiss Vision, Inc.
1040 Worldwide Blvd.
Hebron,  KY  41048
Correspondent Contact Jahmal Cannon
Regulation Number886.1850
Classification Product Code
HJO  
Date Received12/01/2025
Decision Date 03/18/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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