← Product Code [HLZ](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLZ) · K253586

# RM Electrode (RMH 25-01) (K253586)

_Retmap, Inc. · HLZ · Apr 1, 2026 · Ophthalmic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLZ/K253586

## Device Facts

- **Applicant:** Retmap, Inc.
- **Product Code:** [HLZ](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLZ.md)
- **Decision Date:** Apr 1, 2026
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 886.1220
- **Device Class:** Class 2
- **Review Panel:** Ophthalmic

## Regulatory 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).

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**Source:** [https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLZ/K253586](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLZ/K253586)

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