HLGClass I

Pupillometer, Ac-Powered

21 CFR 886.1700 / Ophthalmic

HLG is the FDA product code for Pupillometer, Ac-Powered, a class I device type, regulated under 21 CFR 886.1700. As of 2026-09-10, FDA records hold 3 510(k) clearances under this code, the most recent dated 1992-10-02, and no recalls.

Classification record

Product code: HLG
Device name: Pupillometer, Ac-Powered
Regulation: 21 CFR 886.1700
Device class: Class I
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: 3
Ingested recalls: 0

Clearances, product code HLG

By decision year

3 clearances under product code HLG with a decision year between 1980 and 1992, 1980 the highest year at 1.

Show the numbers

510(k) clearances under FDA product code HLG by decision year
Year	Clearances
1980	1
1989	1
1992	1

Applicants with the most clearances

Product code HLG

Applicants holding the most 510(k) clearances under product code HLG
Applicant	Clearances
Minami, Tomine & Lew	1
Pulse Medical Instruments	1
Trek Medical Products, Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 29 companies shown, in name order

Recent clearances

Product code HLG

Recent recalls

Product code HLG

FDA records show no recalls under product code HLG.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)