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510(k) K253834

Device
VISUREF 600
Applicant
Carl Zeiss Vision GmbH
510(k) number
K253834
Product code
HJO
Decision
Substantially Equivalent (SESE)
Decision date
2026-03-18
Date received
2025-12-01
Regulation
886.1850
Classification name
Biomicroscope, Slit-Lamp, Ac-Powered
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Oliver Jucha-Schade
Address
Turnstrasse 27 Aalen DE 73430 73430

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code HJO#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K231760HP-OCT (HP-OCT)Cylite Pty. , Ltd.2024-03-08
K222372Kowa SL-19Kowa Company , Ltd.2022-11-21
K193188MiiS Horus Eye Anterior CameraMedimaging Integrated Solution, Inc (Miis)2020-01-14
K182306Sunkingdom Slit LampChongqing Sunkingdom Medical Instrument Co., Ltd.2018-11-22
K173771IOLMaster 700Carl Zeiss Meditec, AG2018-08-24
K171877SLM-1ER, SLM-2ER, SLM-3ERChongqing Kanghua Ruiming S&T Co., Ltd.2017-12-21
K170470Digital Eye Anterior CameraMedimaging Integrated Solution, Inc (Miis)2017-10-06
K162778Portable Slit Lamp MicroscopeSuzhou Kangjie Medical, Inc.2017-07-21
K162684SL 220Carl Zeiss Meditec, AG2017-05-31
K163564SLIT LAMP SL-2000Nidek Co., Ltd.2017-05-19
K162636Marco Ultra M3, Marco Ultra M4Takagi Seiko Co., Ltd.2017-04-14
K170171IOLMaster 700Carl Zeiss Meditec, AG2017-04-06
K161607VISULUXCarl Zeiss Meditec, AG2017-02-23
K161764SLIT LAMP, Model: YF-100Chongqing Yeasn Science-Technology Co., Ltd.2017-02-16
K161972Slit Lamp SL-D301Topcon Corporation2016-12-09