Browse hierarchy: [Ophthalmic (OP)](/submissions/OP) → [Subpart B — Diagnostic Devices](/submissions/OP/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 886.1510](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/886.1510) → HLL — Monitor, Eye Movement

# HLL · Monitor, Eye Movement

_Ophthalmic · 21 CFR 886.1510 · Class 2_

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

## Overview

- **Product Code:** HLL
- **Device Name:** Monitor, Eye Movement
- **Regulation:** [21 CFR 886.1510](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/886.1510)
- **Device Class:** 2
- **Review Panel:** [Ophthalmic](/submissions/OP)
- **3rd-party reviewable:** yes

## Identification

An eye movement monitor is an AC-powered device with an electrode intended to measure and record ocular movements.

## Classification Rationale

Class II.

## Recent Cleared Devices (4 of 4)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K222484](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLL/K222484.md) | Retitrack | C. Light Technologies, Inc. | May 9, 2023 | SESE |
| [K152890](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLL/K152890.md) | SACCADOMETER PLUS, SACCADOMETER ADVANCED | Ober Consulting Sp. Z.O.O. | Aug 11, 2016 | SESE |
| [K033949](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLL/K033949.md) | VARILUX VISIONPRINT SYSTEM (VPS) | Essilor Intl. | Jul 2, 2004 | SESE |
| [K872111](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLL/K872111.md) | ORTHOTONE | Orthotone Corp. | Nov 16, 1988 | SESE |

## Top Applicants

- C. Light Technologies, Inc. — 1 clearance
- Essilor Intl. — 1 clearance
- Ober Consulting Sp. Z.O.O. — 1 clearance
- Orthotone Corp. — 1 clearance

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

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