HLJClass II

Ophthalmoscope, Battery-Powered

21 CFR 886.1570 / Ophthalmic

HLJ is the FDA product code for Ophthalmoscope, Battery-Powered, a class II device type, regulated under 21 CFR 886.1570. As of 2026-09-10, FDA records hold 47 510(k) clearances under this code, the most recent dated 2015-05-18, and no recalls.

Classification record

Product code: HLJ
Device name: Ophthalmoscope, Battery-Powered
Regulation: 21 CFR 886.1570
Device class: Class II
Review panel: Ophthalmic
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 47
Ingested recalls: 0

Clearances, product code HLJ

By decision year

47 clearances under product code HLJ with a decision year between 1976 and 2015, 1994 the highest year at 7.

Show the numbers

510(k) clearances under FDA product code HLJ by decision year
Year	Clearances
1976	2
1978	1
1983	2
1984	3
1985	3
1987	2
1989	1
1992	2
1993	5
1994	7
1995	4
1997	2
2000	1
2003	1
2006	3
2007	1
2010	1
2013	3
2014	1
2015	2

Applicants with the most clearances

Product code HLJ

Applicants holding the most 510(k) clearances under product code HLJ
Applicant	Clearances
Rudolf Riester GmbH & Co. KG	6
Heine Optotechnik GmbH & Co. KG.	5
Neitz Instruments Company, Ltd.	5
Design Med. Corp.	3
Keeler Instruments, Inc.	3
R & D Batteries, Inc.	3
Cerenovus, Inc.	2
Randwal Instrument Co., Inc.	2
Access / God Loves You	1
Alexander Mfg. Co.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 64 companies shown, in name order