HLZ · Electrode, Corneal
Ophthalmic · 21 CFR 886.1220 · Class 2
Overview
| Product Code | HLZ |
|---|---|
| Device Name | Electrode, Corneal |
| Regulation | 21 CFR 886.1220 |
| Device Class | Class 2 |
| Review Panel | Ophthalmic |
| 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 | RM Electrode (RMH 25-01) | Retmap, Inc. | Apr 1, 2026 | SESE |
| K232273 | RM Electrode (RMH 23-01) | Retmap, Inc. | Dec 7, 2023 | SESE |
| K961805 | TOMEY DTL ELECTRODE | Tomey Corporation USA | May 9, 1997 | SESE |
| K926540 | SOPHER AND BIERER OVUM FORCEPS | Thomasville Medical Assoc. | Feb 25, 1994 | SESE |
| K913239 | GOLDLENS(TM) | Doran Instruments, Inc. | Jan 31, 1992 | SESE |
| K844409 | DTL ELECTRODE | Sauquoit Industries, Inc. | Feb 14, 1985 | SESE |
| K830557 | ERG-JET ELECTRODE | Universo S.A. | Mar 31, 1983 | SESE |
| K820254 | GOLD FOIL ERG ELECTRODES | Cadwell Laboratories, Inc. | Apr 9, 1982 | SESE |
| K813399 | ERG-JET ELECTRODE | Nicolet Biomedical Instruments | Jan 22, 1982 | SESE |
| K781476 | MULAR GOLD LEAF ELECTRODE MODEL 7501 | Life-Tech Instruments, Inc. | Nov 15, 1978 | SESE |
| K760199 | 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
