Product Code: HLJ FDA class 2 21 CFR 886.1570

Ophthalmoscope, Battery-Powered

Ophthalmic

The Battery-Powered Ophthalmoscope is a portable, handheld ophthalmic instrument used to examine the internal structures of the eye, including the retina, optic disc, and retinal vasculature, enabling diagnosis of conditions such as diabetic retinopathy and glaucoma. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket clearance before marketing. The product code is HLJ, regulated under 21 CFR 886.1570, within the Ophthalmic medical specialty. No special risk flags apply to this device.

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510(k)s

FEI Numbers

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Basic Information

Product Code: HLJ
Device Class: FDA class 2
Regulation Number: 886.1570
Medical Specialty: Ophthalmic
Review Panel: OP
Submission Type: 4

Device Characteristics

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GMP Exempt

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Implant

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Life Sustain/Support

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Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 47 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K142486	HEINE BETA 200, HEINE BETA 200 S, HEINE K 180	May 18, 2015	Substantially Equivalent	Heine Optotechnik GmbH & Co. KG
K142837	HEINE SIGMA 250 & HEINE SIGMA 250 M2	Jan 29, 2015	Substantially Equivalent	Heine Optotechnik GmbH & Co. KG
K131959	HEINE MINI 3000(R) OPHTHALMOSCOPE	Mar 07, 2014	Substantially Equivalent	Heine Optotechnik GmbH & Co. KG
K131961	HEINE BETA 200(R) OPHTHALMOSCOPE	Dec 04, 2013	Substantially Equivalent	Heine Optotechnik GmbH & Co. KG
K131719	OPHTHALMOSCOPES DIAGNOSTIC INSTRUMENT KITS	Oct 30, 2013	Substantially Equivalent	Medical Devices (Pvt) , Ltd.
K123587	HEINE MINI 3000 LED OPHTHALMOSCOPE	Mar 22, 2013	Substantially Equivalent	Heine Optotechnik GmbH & Co. KG
K093495	OTOSCOPE AND OPHTHALMOSCOPE DIAGNOSTIC INSTRUMENT KITS	Nov 19, 2010	Substantially Equivalent	American Diagnostic Corp.
K070270	PICCOLIGHT E50,PICCOLIGHT E56,EUROLIGHT E10, EUROLIGHT E30, AND EUROLIGHT E36	Nov 05, 2007	Substantially Equivalent	Kirchner & Wilhelm GmbH + Co.Kg
K052599	66 VISION TECH OPHTHALMOSCOPE, MODELS YZ6E, YZ6F, YZ6G, YZ11, YZ11C, YZ11D, YZ25A	Nov 07, 2006	Substantially Equivalent	Suzhou 66 Vision Tech Co., Ltd.
K061278	OPTYSE OPHTHALMOSCOPE	May 16, 2006	Substantially Equivalent	Ophthalmos , Ltd.
K053425	PRECISION OPTICS CORPORATION VIDEO OPHTHALMOSCOPE, MODEL 2500-VOS	Jan 09, 2006	Substantially Equivalent	Precision Optics Corp.
K032087	KEELER WIDE ANGLE OPHTHALMOSCOPE MODEL 1130-P-5004	Nov 26, 2003	Substantially Equivalent	Keeler Instruments, Inc.
K002044	MAGNA FORTIS OPHTHALMOSCOPE DIAGNOSTIC KIT	Sep 12, 2000	Substantially Equivalent	Magna Fortis Corporation
K962767	MS401097-17,MS722-K,MS720,MS721,MS722	Jul 03, 1997	Substantially Equivalent	Alexander Mfg. Co.
K970029	KEELER SPECTRA INDIRECT OPHTHALMOSCOPE	Apr 02, 1997	Substantially Equivalent	Keeler Instruments, Inc.
K950914	RI-FORMER WALL MODEL 2,5 V/220 V OR 110 V 3,5 V/220 V OR 110 V, RI-FORMER ANAESTHETIC MODEL 2,5 V/220 V OR 110 C 3,5 V/V	Jul 24, 1995	Substantially Equivalent	Rudolf Riester GmbH & Co. KG
K950797	HALOGEN OPHTHALMO-OTOSCOPE SET BX A - 134	Mar 28, 1995	Substantially Equivalent	Neitz Instruments Company, Ltd.
K950796	HALOGEN DIAGNOSTIC SET BX A - 12345	Mar 22, 1995	Substantially Equivalent	Neitz Instruments Company, Ltd.
K945640	RI-SCOPE S OTOSCOPE	Jan 17, 1995	Unknown	Rudolf Riester GmbH & Co. KG
K944402	FOCOMETER	Nov 22, 1994	Substantially Equivalent	Lacrimedics, Inc.
K942721	NEITZ HALOGEN OPHTHALMOSCOPE BXA-13	Aug 05, 1994	Substantially Equivalent	Neitz Instruments Company, Ltd.
K942719	NEITZ HALOGEN POCKET OPHTHALMOSCOPE A-JR	Aug 05, 1994	Substantially Equivalent	Neitz Instruments Company, Ltd.
K942717	NEITZ HALOGEN OPHTHALMOSCOPE BXA-13A	Aug 05, 1994	Substantially Equivalent	Neitz Instruments Company, Ltd.
K942034	R&D BATTERIES, PART NOS. 5135, 5097, 5444, AND 5502	Jun 03, 1994	Substantially Equivalent	R & D Batteries, Inc.
K936104	R & D BATTERIES	Feb 22, 1994	Substantially Equivalent	R & D Batteries, Inc.
K936018	REPLACEMENT BATTERIES PART NO. 5098,5135, 5097	Feb 22, 1994	Substantially Equivalent	R & D Batteries, Inc.
K925755	DE LUXE	Dec 03, 1993	Unknown	Rudolf Riester GmbH & Co. KG
K925756	UNI II	Oct 18, 1993	Substantially Equivalent	Rudolf Riester GmbH & Co. KG
K932504	RI-FORMER	Oct 15, 1993	Unknown	Rudolf Riester GmbH & Co. KG
K925757	OPHTHALMOSCOPE	Aug 03, 1993	Substantially Equivalent	Rudolf Riester GmbH & Co. KG
K923543	MIS	Mar 29, 1993	Substantially Equivalent	Ceram Optec, Inc.
K922910	MEDICAL BATTERY PACKS	Sep 30, 1992	Substantially Equivalent	Access / God Loves You
K920272	ORIEL	Jul 09, 1992	Substantially Equivalent	Truphatek, Ltd.
K896072	D.L. SCOPE OPHTHALMOSCOPE	Nov 27, 1989	Substantially Equivalent	North American Medical Products, Inc.
K873987	IRAS GLARE TESTER	Nov 24, 1987	Substantially Equivalent	Randwal Instrument Co., Inc.
K871735	VOROSCOPE(TM)	Jun 03, 1987	Substantially Equivalent	Australian Biomedical Corporation , Ltd.
K853891	INDIRECT OPHTHALMOSCOPE	Oct 04, 1985	Substantially Equivalent	Carl Zeiss, Inc.
K852953	#SM-3001 OPHTHA OTOSC SET SUBSETS SOLD	Sep 06, 1985	Substantially Equivalent	Design Med. Corp.
K852334	MODEL BX OPHTHALMOSCOPE(BX-RP INCLUDES BATTE HAN)	Jun 18, 1985	Substantially Equivalent	Design Med. Corp.
K843897	POCKET OPHTHALMOSCOPE GH	Nov 27, 1984	Substantially Equivalent	Design Med. Corp.
K842567	PORTABLE ACUIOMETER	Aug 15, 1984	Substantially Equivalent	Randwal Instrument Co., Inc.
K841292	SPECTACLE INDIRECT OPHTHALMOSCOPE	May 09, 1984	Substantially Equivalent	Keller Instruments, Inc.
K832437	MEDIC LUX DIAGNOSTIC SETS	Aug 16, 1983	Substantially Equivalent	Keeler Instruments, Inc.
K830215	DORC LIGHTWEIGHT BINOCULAR OPHTHALMOSCOP	Mar 09, 1983	Substantially Equivalent	Jedmed Instrument Co.
K780215	EYESCOPE	Apr 10, 1978	Substantially Equivalent	Visual Methods, Inc.
K760771	SOLA SCHULTZE-CROCK OPTHALMOSCOPE	Oct 15, 1976	Substantially Equivalent	Codman & Shurtleff, Inc.
K760770	SOLA COMMIDO LOUPE	Oct 15, 1976	Substantially Equivalent	Codman & Shurtleff, Inc.