21 CFR 886.1220 — Electrode, Corneal
Ophthalmic (OP) · Part 886 Subpart B—Diagnostic Devices · § 886.1220
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| HLZ | Electrode, Corneal | 2 | 11 | 3rd Party |
