HJO · Class II · 21 CFR 886.1850

FDA Product Code HJO: Biomicroscope, Slit-lamp, Ac-powered

Leading manufacturers include Carl Zeiss Meditec, AG, Carl Zeiss, Inc. and Bausch & Lomb, Inc..

109
Total
109
Cleared
126d
Avg days
1980
Since
Stable submission activity - 2 submissions in the last 2 years
Review times improving: avg 79d recently vs 127d historically

FDA 510(k) Cleared Biomicroscope, Slit-lamp, Ac-powered Devices (Product Code HJO)

109 devices
1–24 of 109
Cleared Sep 18, 2026
SLIT LAMP SL-D4 (Type: LED)
K262637
Topcon Corporation
Ophthalmic · 51d
Cleared Mar 18, 2026
VISUREF 600
K253834
Carl Zeiss Vision GmbH
Ophthalmic · 107d
Cleared Mar 08, 2024
HP-OCT (HP-OCT)
K231760
Cylite Pty. , Ltd.
Ophthalmic · 266d
Cleared Nov 21, 2022
Kowa SL-19
K222372
Kowa Company , Ltd.
Ophthalmic · 108d
Cleared Jan 14, 2020
MiiS Horus Eye Anterior Camera
K193188
Medimaging Integrated Solution, Inc (Miis)
Ophthalmic · 57d
Cleared Nov 22, 2018
Sunkingdom Slit Lamp
K182306
Chongqing Sunkingdom Medical Instrument Co., Ltd.
Ophthalmic · 90d
Cleared Aug 24, 2018
IOLMaster 700
K173771
Carl Zeiss Meditec, AG
Ophthalmic · 256d
Cleared Dec 21, 2017
SLM-1ER, SLM-2ER, SLM-3ER
K171877
Chongqing Kanghua Ruiming S&T Co., Ltd.
Ophthalmic · 181d
Cleared Oct 06, 2017
Digital Eye Anterior Camera
K170470
Medimaging Integrated Solution, Inc (Miis)
Ophthalmic · 232d
Cleared Jul 21, 2017
Portable Slit Lamp Microscope
K162778
Suzhou Kangjie Medical, Inc.
Ophthalmic · 294d
Cleared May 31, 2017
SL 220
K162684
Carl Zeiss Meditec, AG
Ophthalmic · 247d
Cleared May 19, 2017
SLIT LAMP SL-2000
K163564
Nidek Co., Ltd.
Ophthalmic · 151d
Cleared Apr 14, 2017
Marco Ultra M3, Marco Ultra M4
K162636
Takagi Seiko Co., Ltd.
Ophthalmic · 205d
Cleared Apr 06, 2017
IOLMaster 700
K170171
Carl Zeiss Meditec, AG
Ophthalmic · 77d
Cleared Feb 23, 2017
VISULUX
K161607
Carl Zeiss Meditec, AG
Ophthalmic · 258d
Cleared Feb 16, 2017
SLIT LAMP, Model: YF-100
K161764
Chongqing Yeasn Science-Technology Co., Ltd.
Ophthalmic · 234d
Cleared Dec 09, 2016
Slit Lamp SL-D301
K161972
Topcon Corporation
Ophthalmic · 144d
Cleared Oct 05, 2016
ALADDIN HW3.0
K160327
Visia Imaging S.R.L.
Ophthalmic · 243d
Cleared Jun 22, 2016
Portable Slit Lamp
K153545
Shanghai Bolan Optical-Electric Co., Ltd.
Ophthalmic · 194d
Cleared May 26, 2016
Z5 Slit lamp microscope, Z2 Slit lamp microscope
K152535
Takagi Seiko Co., Ltd.
Ophthalmic · 265d
Cleared May 11, 2016
Slit Lamp Microscope
K152429
Shanghai Mediworks Precision Instruments Co. , Ltd.
Ophthalmic · 259d
Cleared Sep 10, 2015
Keeler Slit Lamp
K151394
Keeler Limited
Ophthalmic · 107d
Cleared Jul 10, 2015
IOLMaster700
K143275
Carl Zeiss Meditec, Inc.
Ophthalmic · 238d
Cleared Oct 15, 2014
XCEL 455 SLIT LAMP
K141954
Reichert, Inc.
Ophthalmic · 89d

About Product Code HJO - Regulatory Context

510(k) Submission Activity

109 total 510(k) submissions under product code HJO since 1980, with 109 receiving FDA clearance (average review time: 126 days).

Submission volume has remained relatively stable over the observed period, with 2 submissions in the last 24 months.

FDA 510(k) Review Time - HJO Product Code

Recent submissions under HJO have taken an average of 79 days to reach a decision - down from 127 days historically, suggesting improved FDA processing for this classification.

HJO devices are reviewed by the Ophthalmic panel. Browse all Ophthalmic devices →