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..

108
Total
108
Cleared
127d
Avg days
1980
Since
Declining activity - 1 submissions in the last 2 years vs 2 in the prior period
Review times improving: avg 107d recently vs 127d historically

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

108 devices
1–24 of 108
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 May 31, 2017
SL 220
K162684
Carl Zeiss Meditec, AG
Ophthalmic · 247d
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 Sep 09, 2014
ZEISS CATARACT SUITE MARKERLESS
K141068
Carl Zeiss Meditec, AG
Ophthalmic · 138d
Cleared Feb 12, 2014
SLIT LAMPS WITH SL CAM 5.0 DIGITAL IMAGING SOLUTION
K133476
Carl Zeiss Meditec, AG
Ophthalmic · 92d
Cleared Apr 12, 2013
IOLMASTER 500
K122418
Carl Zeiss Meditec, AG
Ophthalmic · 247d
Cleared Nov 03, 2010
IOLMASTER 500
K101182
Carl Zeiss Meditec, AG
Ophthalmic · 190d
Cleared Mar 09, 2010
PSL CLASSIC SLIT LAMP
K100500
Keeler Instruments, Inc.
Ophthalmic · 15d
Cleared Nov 19, 2001
DOCUMENTING LASER SLIT LAMP, DP 2010
K012873
Bausch & Lomb, Inc.
Ophthalmic · 84d
Cleared Mar 20, 2000
IOLMASTER
K993357
Carl Zeiss, Inc.
Ophthalmic · 166d
Cleared Apr 07, 1998
KEELER TEARSCOPE-PLUS
K973064
Keeler Instruments, Inc.
Ophthalmic · 232d
Cleared Apr 01, 1994
SLIT LAMP, H-201
K936209
Canon USA, Inc.
Ophthalmic · 93d
Cleared Sep 09, 1993
ZEISS 20 SL SLIT-LAMP & MECHANICAL MICROMANIPULATR
K925641
Carl Zeiss, Inc.
Ophthalmic · 304d
Cleared Jan 27, 1988
ZEISS 40 SL/P PHOTO SLIT LAMP
K874160
Carl Zeiss, Inc.
Ophthalmic · 106d
Cleared Dec 23, 1987
OCS 100 (OCULAR COMPARATOR SYSTEM)
K874220
Ocular Instruments, Inc.
Ophthalmic · 68d
Cleared Jul 11, 1986
BAUSCH & LOMB CSL-1000 SLIT LAMP
K862515
Bausch & Lomb, Inc.
Ophthalmic · 10d
Cleared Jul 11, 1986
BAUSCH & LOMB OSL-2000 SLIT LAMP
K862516
Bausch & Lomb, Inc.
Ophthalmic · 10d
Cleared Jul 11, 1986
BAUSCH & LOMB PSL-3000 SLIT LAMP
K862520
Bausch & Lomb, Inc.
Ophthalmic · 10d

About Product Code HJO - Regulatory Context

510(k) Submission Activity

108 total 510(k) submissions under product code HJO since 1980, with 108 receiving FDA clearance (average review time: 127 days).

Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 2 in the prior period.

FDA 510(k) Review Time - HJO Product Code

Recent submissions under HJO have taken an average of 107 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 →