Browse hierarchy: [Ophthalmic (OP)](/submissions/OP) → [Subpart B — Diagnostic Devices](/submissions/OP/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 886.1690](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/886.1690) → HRI — Pupillograph

# HRI · Pupillograph

_Ophthalmic · 21 CFR 886.1690 · Class 1_

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

## Overview

- **Product Code:** HRI
- **Device Name:** Pupillograph
- **Regulation:** [21 CFR 886.1690](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/886.1690)
- **Device Class:** 1
- **Review Panel:** [Ophthalmic](/submissions/OP)

## Identification

A pupillograph is an AC-powered device intended to measure the pupil of the eye by reflected light and record the responses of the pupil.

## Classification Rationale

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9.

## Recent Cleared Devices (0 of 0)

_No cleared devices on record._

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

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