RM Electrode (RMH 25-01)
Device Facts
| Record ID | K253586 |
|---|---|
| Device Name | RM Electrode (RMH 25-01) |
| Applicant | Retmap, Inc. |
| Product Code | HLZ · Ophthalmic |
| Decision Date | Apr 1, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 886.1220 |
| Device Class | Class 2 |
Regulatory Classification
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).
