Browse hierarchy: [Ophthalmic (OP)](/submissions/OP) → [Subpart B — Diagnostic Devices](/submissions/OP/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 886.1220](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/886.1220) → HLZ — Electrode, Corneal

# HLZ · Electrode, Corneal

_Ophthalmic · 21 CFR 886.1220 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLZ

## Overview

- **Product Code:** HLZ
- **Device Name:** Electrode, Corneal
- **Regulation:** [21 CFR 886.1220](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/886.1220)
- **Device Class:** 2
- **Review Panel:** [Ophthalmic](/submissions/OP)
- **3rd-party reviewable:** yes

## Identification

A corneal electrode is an AC-powered device, usually part of a special contact lens, intended to be applied directly to the cornea to provide data showing the changes in electrical potential in the retina after electroretinography (stimulation by light).

## Classification Rationale

Class II.

## Recent Cleared Devices (11 of 11)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K253586](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLZ/K253586.md) | RM Electrode (RMH 25-01) | Retmap, Inc. | Apr 1, 2026 | SESE |
| [K232273](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLZ/K232273.md) | RM Electrode (RMH 23-01) | Retmap, Inc. | Dec 7, 2023 | SESE |
| [K961805](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLZ/K961805.md) | TOMEY DTL ELECTRODE | Tomey Corporation USA | May 9, 1997 | SESE |
| [K926540](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLZ/K926540.md) | SOPHER AND BIERER OVUM FORCEPS | Thomasville Medical Assoc. | Feb 25, 1994 | SESE |
| [K913239](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLZ/K913239.md) | GOLDLENS(TM) | Doran Instruments, Inc. | Jan 31, 1992 | SESE |
| [K844409](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLZ/K844409.md) | DTL ELECTRODE | Sauquoit Industries, Inc. | Feb 14, 1985 | SESE |
| [K830557](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLZ/K830557.md) | ERG-JET ELECTRODE | Universo S.A. | Mar 31, 1983 | SESE |
| [K820254](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLZ/K820254.md) | GOLD FOIL ERG ELECTRODES | Cadwell Laboratories, Inc. | Apr 9, 1982 | SESE |
| [K813399](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLZ/K813399.md) | ERG-JET ELECTRODE | Nicolet Biomedical Instruments | Jan 22, 1982 | SESE |
| [K781476](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLZ/K781476.md) | MULAR GOLD LEAF ELECTRODE MODEL 7501 | Life-Tech Instruments, Inc. | Nov 15, 1978 | SESE |
| [K760199](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLZ/K760199.md) | ELECTRORETINOGRAPH | Lkc Technologies, Inc. | Aug 4, 1976 | SESE |

## Top Applicants

- Retmap, Inc. — 2 clearances
- Cadwell Laboratories, Inc. — 1 clearance
- Doran Instruments, Inc. — 1 clearance
- Life-Tech Instruments, Inc. — 1 clearance
- Lkc Technologies, Inc. — 1 clearance

---

**Source:** [https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLZ](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLZ)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com