Browse hierarchy: [Neurology (NE)](/submissions/NE) → [Subpart F — Neurological Therapeutic Devices](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices) → [21 CFR 882.5811](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/882.5811) → QEO — Light Attenuation Lenses For Migraine-Associated Light Sensitivity

# QEO · Light Attenuation Lenses For Migraine-Associated Light Sensitivity

_Neurology · 21 CFR 882.5811 · Class 1_

**Canonical URL:** https://fda-staging.innolitics.com/productcode/QEO

## Overview

- **Product Code:** QEO
- **Device Name:** Light Attenuation Lenses For Migraine-Associated Light Sensitivity
- **Regulation:** [21 CFR 882.5811](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/882.5811)
- **Device Class:** 1
- **Review Panel:** [Neurology](/submissions/NE)

## Identification

Light attenuation lenses for migraine-associated light sensitivity are devices that limit light incidence of specific wavelengths to the eyes and are intended to decrease the impact of light sensitivity in patients diagnosed with migraine. The lenses can be mounted on a spectacle frame, clips, or other apertures used to hold lenses. The device is intended to be adjunctive to other therapies for migraine-associated light sensitivity.

## Classification Rationale

FDA has determined that the device can be classified in class I. FDA believes that class I (general) controls provide reasonable assurance of the safety and effectiveness of the device type.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [DEN250026](/device/DEN250026.md) | Avulux | Matap Ii, LLC | Aug 21, 2026 | DENG |

## Top Applicants

- Matap Ii, LLC — 1 clearance

---

**Source:** [https://fda-staging.innolitics.com/productcode/QEO](https://fda-staging.innolitics.com/productcode/QEO)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com