510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN250026Unknown

Avulux

Matap Ii, LLC, Aventura FL / Direct, Unknown
FDA source (opens on fda.gov)

DEN250026 is the FDA 510(k) clearance record for Avulux, a class I device, cleared for Matap Ii, LLC on under FDA product code QEO (Light Attenuation Lenses For Migraine-Associated Light Sensitivity). FDA's definition for product code QEO 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...". As of , FDA records show no recalls naming DEN250026.

Clearance record

Decision date
Received
(424 days to decision)
Product code
QEO Light Attenuation Lenses For Migraine-Associated Light Sensitivity
Regulation
21 CFR 882.5811
Device class
Class I
Review panel
Neurology
Applicant
Matap Ii, LLC 18117 Biscayne Blvd., Aventura FL
Third party review
No

Clearances, product code QEO

Trailing 12 months
1 clearance under product code QEO in the twelve months to October 2026, August 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code QEO, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260