HLIClass II

Ophthalmoscope, Ac-Powered

21 CFR 886.1570 / Ophthalmic

HLI is the FDA product code for Ophthalmoscope, Ac-Powered, a class II device type, regulated under 21 CFR 886.1570. As of 2026-09-10, FDA records hold 87 510(k) clearances under this code, the most recent dated 2016-02-11, and 7 recalls.

Classification record

Product code: HLI
Device name: Ophthalmoscope, Ac-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: 87
Ingested recalls: 7

Clearances, product code HLI

By decision year

87 clearances under product code HLI with a decision year between 1977 and 2016, 1994 the highest year at 12.

Show the numbers

510(k) clearances under FDA product code HLI by decision year
Year	Clearances
1977	2
1979	1
1982	1
1984	8
1985	7
1987	1
1988	1
1989	4
1990	1
1991	4
1992	2
1993	2
1994	12
1995	4
1996	1
1997	3
1998	1
1999	1
2000	3
2001	1
2003	2
2004	3
2005	2
2006	3
2007	1
2010	2
2011	3
2012	2
2013	2
2014	4
2015	2
2016	1

Applicants with the most clearances

Product code HLI

Applicants holding the most 510(k) clearances under product code HLI
Applicant	Clearances
Carl Zeiss Meditec Inc	7
Neitz Instruments Company, Ltd.	7
Optovue Inc.	7
Keeler Instruments, Inc.	6
Heidelberg Engineering GmbH	5
Talia Technology, Ltd.	5
Welch Allyn Inc	5
Woodlyn, Inc.	5
American Medical Optics	3
Bioptigen, Inc.	3

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 53 companies shown, in name order