Product Code: HJO FDA class 2 21 CFR 886.1850

Biomicroscope, Slit-Lamp, Ac-Powered

Ophthalmic

The AC-Powered Slit-Lamp Biomicroscope is a diagnostic ophthalmic instrument combining a high-intensity slit light source with a binocular microscope, allowing detailed examination of the anterior and posterior segments of the eye including the cornea, lens, and retina. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket clearance demonstrating substantial equivalence to a predicate device. The product code is HJO, regulated under 21 CFR 886.1850, within the Ophthalmic medical specialty. This device is eligible for third-party 510(k) review by an FDA-accredited reviewer.

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510(k)s

108

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: HJO
Device Class: FDA class 2
Regulation Number: 886.1850
Medical Specialty: Ophthalmic
Review Panel: OP
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 108 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K253834	VISUREF 600	Mar 18, 2026	Substantially Equivalent	Carl Zeiss Vision GmbH
K231760	HP-OCT (HP-OCT)	Mar 08, 2024	Substantially Equivalent	Cylite Pty. , Ltd.
K222372	Kowa SL-19	Nov 21, 2022	Substantially Equivalent	Kowa Company , Ltd.
K193188	MiiS Horus Eye Anterior Camera	Jan 14, 2020	Substantially Equivalent	Medimaging Integrated Solution, Inc (Miis)
K182306	Sunkingdom Slit Lamp	Nov 22, 2018	Substantially Equivalent	Chongqing Sunkingdom Medical Instrument Co., Ltd.
K173771	IOLMaster 700	Aug 24, 2018	Substantially Equivalent	Carl Zeiss Meditec, AG
K171877	SLM-1ER, SLM-2ER, SLM-3ER	Dec 21, 2017	Substantially Equivalent	Chongqing Kanghua Ruiming S&T Co., Ltd.
K170470	Digital Eye Anterior Camera	Oct 06, 2017	Substantially Equivalent	Medimaging Integrated Solution, Inc (Miis)
K162778	Portable Slit Lamp Microscope	Jul 21, 2017	Substantially Equivalent	Suzhou Kangjie Medical, Inc.
K162684	SL 220	May 31, 2017	Substantially Equivalent	Carl Zeiss Meditec, AG
K163564	SLIT LAMP SL-2000	May 19, 2017	Substantially Equivalent	Nidek Co., Ltd.
K162636	Marco Ultra M3, Marco Ultra M4	Apr 14, 2017	Substantially Equivalent	Takagi Seiko Co., Ltd.
K170171	IOLMaster 700	Apr 06, 2017	Substantially Equivalent	Carl Zeiss Meditec, AG
K161607	VISULUX	Feb 23, 2017	Substantially Equivalent	Carl Zeiss Meditec, AG
K161764	SLIT LAMP, Model: YF-100	Feb 16, 2017	Substantially Equivalent	Chongqing Yeasn Science-Technology Co., Ltd.
K161972	Slit Lamp SL-D301	Dec 09, 2016	Substantially Equivalent	Topcon Corporation
K160327	ALADDIN HW3.0	Oct 05, 2016	Substantially Equivalent	Visia Imaging S.R.L.
K153545	Portable Slit Lamp	Jun 22, 2016	Substantially Equivalent	Shanghai Bolan Optical-Electric Co., Ltd.
K152535	Z5 Slit lamp microscope, Z2 Slit lamp microscope	May 26, 2016	Substantially Equivalent	Takagi Seiko Co., Ltd.
K152429	Slit Lamp Microscope	May 11, 2016	Substantially Equivalent	Shanghai Mediworks Precision Instruments Co. , Ltd.
K151394	Keeler Slit Lamp	Sep 10, 2015	Substantially Equivalent	Keeler Limited
K143275	IOLMaster700	Jul 10, 2015	Substantially Equivalent	Carl Zeiss Meditec, Inc.
K141954	XCEL 455 SLIT LAMP	Oct 15, 2014	Substantially Equivalent	Reichert, Inc.
K141068	ZEISS CATARACT SUITE MARKERLESS	Sep 09, 2014	Substantially Equivalent	Carl Zeiss Meditec, AG
K133667	SLIT LAMP SL-D701	Aug 26, 2014	Substantially Equivalent	Topcon Corp.
K140451	KEELER SLIT LAMP H-SERIES DIGITAL (HALOGEN BULB OPTION), KEELER SLIT LAMP H-SERIES DIGITAL (LED OPTION)	Jul 11, 2014	Substantially Equivalent	Keeler Limited
K133062	DISCOVERY SYSTEM	Jun 20, 2014	Substantially Equivalent	Innovative Visual Systems
K133132	OPTICAL BIOMETER AL-SCAN	Jun 11, 2014	Substantially Equivalent	Nidek Co., Ltd.
K131567	ALADDIN	Jun 05, 2014	Substantially Equivalent	Visia Imaging S.R.L.
K131711	YZ3 PORTABLE SLIT LAMP	May 09, 2014	Substantially Equivalent	Suzhou 66 Vision Tech Co., Ltd.
K133755	KOWA SL-17	Mar 11, 2014	Substantially Equivalent	Kowa Co. , Ltd.
K133476	SLIT LAMPS WITH SL CAM 5.0 DIGITAL IMAGING SOLUTION	Feb 12, 2014	Substantially Equivalent	Carl Zeiss Meditec, AG
K131589	KEELER SLIT LAMP H-SERIES	Jun 27, 2013	Substantially Equivalent	Keeler, Ltd.
K122418	IOLMASTER 500	Apr 12, 2013	Substantially Equivalent	Carl Zeiss Meditec, AG
K110129	RIGHTON ZOOM SLIT LAMP MICROSCOPE WITH PHOTO OPTION	Aug 30, 2011	Substantially Equivalent	Rightmedical Products, LLC
K110489	SLIT LAMP SL-2G	May 23, 2011	Substantially Equivalent	Topcon Medical Systems, Inc.
K101182	IOLMASTER 500	Nov 03, 2010	Substantially Equivalent	Carl Zeiss Meditec, AG
K100439	MEDIWORKS SLIT LAMP	Jul 16, 2010	Substantially Equivalent	Shanghai Mediworks Precision Instruments Co. , Ltd.
K100202	SLIT LAMP BO 900, BQ 900, BP900	Mar 19, 2010	Substantially Equivalent	Haag-Streit AG
K100500	PSL CLASSIC SLIT LAMP	Mar 09, 2010	Substantially Equivalent	Keeler Instruments, Inc.
K093021	ATLANTIS SLIT LAMP	Jan 28, 2010	Substantially Equivalent	Us Opthalmic, LLC
K092883	LED LAMP OR OTHER	Dec 18, 2009	Substantially Equivalent	Intravista Medical Systems, Inc.
K093639	SLIT LAMP, MODELS HS-5000, HS-5500 AND HS-7500	Dec 03, 2009	Substantially Equivalent	Huvitz Co., Ltd.
K082891	LENSTAR, MODEL LS900	Oct 20, 2009	Substantially Equivalent	Haag-Streit AG
K080776	GILRAS SLIT LAMP, MODELS GR-SL7, GR-SL36, GR-SL54 AND GR-SL72	Sep 09, 2008	Substantially Equivalent	Us Ophthalmic, LLC
K082031	APPASAMY SLIT LAMP, A1A-11 AND A1A-12 SERIES	Jul 31, 2008	Substantially Equivalent	Appasamy Associates
K072861	CEEMAX SLIT LAMP (HALOGEN LAMP SERIES/SOLID STATE ILLUMINATION SERIES)	Jun 24, 2008	Substantially Equivalent	Acheve Technology, Inc.
K073190	SLIT LAMP	Jan 11, 2008	Substantially Equivalent	Huvitz Co., Ltd.
K063352	ELLEX SLIT LAMP, MODEL 30XL	Mar 13, 2007	Substantially Equivalent	Takagi Seiko Co., Ltd.
K063750	XCEL 255 SLIT LAMP	Dec 20, 2006	Substantially Equivalent	Reichert, Inc.
K063640	KOWA SL-15	Dec 18, 2006	Substantially Equivalent	Kowa Co. , Ltd.
K063416	LUXVISION SLIT LAMP	Dec 07, 2006	Substantially Equivalent	Us Ophthalmic, LLC
K061330	PSL PORTABLE SLIT LAMP	May 25, 2006	Substantially Equivalent	Reichert, Inc.
K060869	RS-1000 ZOOM SLITLAMP WITH OPTION	May 11, 2006	Substantially Equivalent	Rightmedical Products, LLC
K043503	VISX CUSTOMVUE SLIT ILLUMINATOR WITH DESKTOP CHARGER, MODEL CV SI-1	Apr 05, 2005	Substantially Equivalent	Visx, Incorporated
K033190	VISION-TECH YZ SLIT LAMP, MODEL 66	Dec 04, 2003	Substantially Equivalent	Suzhou 66 Vision-Tech Co., Ltd.
K012873	DOCUMENTING LASER SLIT LAMP, DP 2010	Nov 19, 2001	Substantially Equivalent	Bausch & Lomb, Inc.
K012416	CONFOSCAN 2 CONFOCAL MICROSCOPE	Oct 26, 2001	Substantially Equivalent	Nidek Technologies Srl
K993357	IOLMASTER	Mar 20, 2000	Substantially Equivalent	Carl Zeiss, Inc.
K992836	SL990, SL980, SL950	Nov 09, 1999	Substantially Equivalent	Cso
K982057	BC 900 SLIT LAMP	Aug 14, 1998	Substantially Equivalent	Haag-Streit AG
K973064	KEELER TEARSCOPE-PLUS	Apr 07, 1998	Substantially Equivalent	Keeler Instruments, Inc.
K974467	AESCULAP-MEDITEC SLIT LAMPS SL07 AND SL08	Feb 19, 1998	Substantially Equivalent	Aesculap-Meditec North America
K971953	CONFOSCAN	Aug 14, 1997	Substantially Equivalent	Tomey Corporation USA
K970414	CONFOCAL MICROSCOPE	Jul 15, 1997	Substantially Equivalent	Con-S , Ltd.
K962532	RODENSTOCK SLITLAMP (MODEL 5000 & 4000)	Jul 25, 1996	Substantially Equivalent	Expertech Assoc., Inc.
K962522	MODEL SL-YZ5E	Jul 25, 1996	Substantially Equivalent	Pacific Ophthalmic Supply
K954782	KOWA PORTABLE SLIT LAMP SL-14 & SL-14B	Nov 24, 1995	Substantially Equivalent	Kowa Optimed, Inc.
K945445	BOBES SLIT LAMP	Oct 17, 1995	Substantially Equivalent	Bobes S.A.
K953965	904 SLIT LAMP	Sep 27, 1995	Substantially Equivalent	Clement Clarke, Inc.
K953030	SLIT LAMP AIA 11	Jul 12, 1995	Substantially Equivalent	Naveen Intl., Inc.
K951341	NEITZ SLIT LAMP SL-H2	Jun 15, 1995	Substantially Equivalent	Neitz Instruments Company, Ltd.
K951184	OTI MODEL 78-60	May 12, 1995	Substantially Equivalent	Oti Medical, LLC
K951340	NEITZ SLIT LAMP SL-H1	Apr 10, 1995	Substantially Equivalent	Neitz Instruments Company, Ltd.
K951054	XCEL SLIT LAMP	Mar 22, 1995	Substantially Equivalent	Leica, Inc.
K944910	TOMEY EM-1000 SPECULAR MICROSCOPE	Nov 22, 1994	Substantially Equivalent	Tomey Corporation USA
K936209	SLIT LAMP, H-201	Apr 01, 1994	Substantially Equivalent	Canon USA, Inc.
K930518	TALIA LASER SLIT	Jan 25, 1994	Substantially Equivalent	Talia Technology , Ltd.
K925641	ZEISS 20 SL SLIT-LAMP & MECHANICAL MICROMANIPULATR	Sep 09, 1993	Substantially Equivalent	Carl Zeiss, Inc.
K930438	MARCO MODELS G,H AND PRIMARY CARE SLIT LAMPS	Aug 09, 1993	Substantially Equivalent	Marco Ophthalmic, Inc.
K924783	BURTON SLIT LAMP - MODEL 850	Apr 14, 1993	Substantially Equivalent	R.H. Burton Co.
K924787	BURTON SLIT LAMP	Jan 27, 1993	Substantially Equivalent	R.H. Burton Co.
K924782	BURTON SLIT LAMP - MODEL 2000	Jan 27, 1993	Substantially Equivalent	R.H. Burton Co.
K924770	BURTON HAND HELD SLIT LAMP - MODEL SL750	Jan 27, 1993	Substantially Equivalent	R.H. Burton Co.
K915356	OPACITRAC	Feb 21, 1992	Substantially Equivalent	Oculon Corp.
K913852	LASER FLARE METER	Feb 07, 1992	Substantially Equivalent	Kowa Optimed, Inc.
K912514	TANDEM SCANNING MICROSCOPE	Dec 16, 1991	Substantially Equivalent	Tandem Scanning Corp.
K910980	SITE 20 GAUGE REUSABLE FIBER OPTIC CABLE	May 22, 1991	Substantially Equivalent	Site Microsurgical Systems, Inc.
K900477	WOODLYN CLASSIC SLIT LAMP MODEL SMM	Feb 21, 1990	Substantially Equivalent	Woodlyn, Inc.
K900476	WOODLYN SLIT LAMP MODEL HR-1	Feb 21, 1990	Substantially Equivalent	Woodlyn, Inc.
K880920	LASER FLARE CELL METER FC-1000	Sep 27, 1988	Substantially Equivalent	Kowa Optimed, Inc.
K874160	ZEISS 40 SL/P PHOTO SLIT LAMP	Jan 27, 1988	Substantially Equivalent	Carl Zeiss, Inc.
K874220	OCS 100 (OCULAR COMPARATOR SYSTEM)	Dec 23, 1987	Substantially Equivalent	Ocular Instruments, Inc.
K863970	MLC ENDOTHELIAL CELL COUNTER	Dec 29, 1986	Substantially Equivalent	Mlc Technologies
K863048	OPM SLIT LAMP MODEL P-1 & MODEL P-3	Sep 03, 1986	Substantially Equivalent	Optek Medico Co., Ltd.
K862379	CORNEAL MODELING SYSTEM	Aug 25, 1986	Substantially Equivalent	Computed Anatomy, Inc.
K862520	BAUSCH & LOMB PSL-3000 SLIT LAMP	Jul 11, 1986	Substantially Equivalent	Bausch & Lomb, Inc.
K862516	BAUSCH & LOMB OSL-2000 SLIT LAMP	Jul 11, 1986	Substantially Equivalent	Bausch & Lomb, Inc.
K862515	BAUSCH & LOMB CSL-1000 SLIT LAMP	Jul 11, 1986	Substantially Equivalent	Bausch & Lomb, Inc.
K861854	OPM SLIT LAMP MODEL P-1	Jul 11, 1986	Substantially Equivalent	Optek Medico Co., Ltd.
K862004	ZEISS 30 SL-L	Jun 17, 1986	Substantially Equivalent	Carl Zeiss, Inc.
K842859	MICROSCOPE MITTS SUPPORT TRAY COVER	Oct 05, 1984	Substantially Equivalent	Chiron Vision Corp.
K832911	ABBOTT GLOBE HOLDER	Sep 29, 1983	Substantially Equivalent	Miami Eye Technology, Inc.
K813313	BIOMICROSCOPY CONTACT LENS	Mar 01, 1982	Substantially Equivalent	Design Research Assoc., Inc.
K811153	COHERENT FLOUROTRON MASTER	Jun 16, 1981	Substantially Equivalent	Lumenis, Inc.
K810403	KEELER/KONAN SPECULAR MICROSCOPE	May 13, 1981	Substantially Equivalent	Keeler Optical Products , Ltd.
K802355	METRICON #120 FLUOROPHOTOMETER	Dec 17, 1980	Substantially Equivalent	Metricon, Ltd.
K801659	BIOPHTAL CLINICAL ENDOTHELIAL MICROSCOPE	Sep 09, 1980	Substantially Equivalent	Coburn Optical Ind., Inc.