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QEOClass I

Light Attenuation Lenses For Migraine-Associated Light Sensitivity

21 CFR 882.5811 / Neurology

QEO is the FDA product code for Light Attenuation Lenses For Migraine-Associated Light Sensitivity, a class I device type, regulated under 21 CFR 882.5811. FDA's definition for this code reads: "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...". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
QEO
Device name
Light Attenuation Lenses For Migraine-Associated Light Sensitivity
FDA definition
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. Sunglasses (nonprescription) and prescription spectacle lenses are separately classified under § 886.5850 and § 886.5844, respectively.
Regulation
21 CFR 882.5811
Device class
Class I
Review panel
Neurology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code QEO

By decision year
1 clearance under product code QEO with a decision year between 2026 and 2026, 2026 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QEO by decision year
YearClearances
20261

Applicants with the most clearances

Product code QEO
Applicants holding the most 510(k) clearances under product code QEO
ApplicantClearances
Matap Ii, LLC1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code QEO.