Electrode, Corneal
The Corneal Electrode is a specialized ophthalmic electrode placed on or near the corneal surface, used in electroretinography (ERG) and other electrophysiological tests to record the electrical activity of the retina in response to light stimulation. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket clearance before marketing. The product code is HLZ, regulated under 21 CFR 886.1220, within the Ophthalmic medical specialty. This device is eligible for third-party 510(k) review by an FDA-accredited reviewer.
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Basic Information
- Product Code
- HLZ
- Device Class
- FDA class 2
- Regulation Number
- 886.1220
- Medical Specialty
- Ophthalmic
- Review Panel
- OP
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 11 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K253586 | RM Electrode (RMH 25-01) | Apr 01, 2026 | Substantially Equivalent | Retmap, Inc. |
| K232273 | RM Electrode (RMH 23-01) | Dec 07, 2023 | Substantially Equivalent | Retmap, Inc. |
| K961805 | TOMEY DTL ELECTRODE | May 09, 1997 | Substantially Equivalent | Tomey Corporation USA |
| K926540 | SOPHER AND BIERER OVUM FORCEPS | Feb 25, 1994 | Substantially Equivalent | Thomasville Medical Assoc. |
| K913239 | GOLDLENS(TM) | Jan 31, 1992 | Substantially Equivalent | Doran Instruments, Inc. |
| K844409 | DTL ELECTRODE | Feb 14, 1985 | Substantially Equivalent | Sauquoit Industries, Inc. |
| K830557 | ERG-JET ELECTRODE | Mar 31, 1983 | Substantially Equivalent | Universo S.A. |
| K820254 | GOLD FOIL ERG ELECTRODES | Apr 09, 1982 | Substantially Equivalent | Cadwell Laboratories, Inc. |
| K813399 | ERG-JET ELECTRODE | Jan 22, 1982 | Substantially Equivalent | Nicolet Biomedical Instruments |
| K781476 | MULAR GOLD LEAF ELECTRODE MODEL 7501 | Nov 15, 1978 | Substantially Equivalent | Life-Tech Instruments, Inc. |
| K760199 | ELECTRORETINOGRAPH | Aug 04, 1976 | Substantially Equivalent | Lkc Technologies, Inc. |
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.