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K Number
K253586

Validate with FDA (Live)

Device Name
RM Electrode (RMH 25-01)
Manufacturer
Retmap, Inc.
Date Cleared
2026-04-01

(135 days)

Product Code
HLZ
Regulation Number
886.1220
Type
Traditional
Panel
Ophthalmic
Age Range
N/A
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

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§ 886.1220 Corneal electrode.

(a)
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).(b)
Classification. Class II.