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The Tracker / August 2026 / DEN250026

510(k) cleared

Avulux

Matap Ii, LLC · Aug 21, 2026 · DEN250026

FDA cleared the Avulux from Matap Ii, LLC on Aug 21, 2026 under DEN250026, a direct 510(k). The device falls under product code QEO, Light Attenuation Lenses For Migraine-Associated Light Sensitivity, regulated at 21 CFR 882.5811 as a Class 1 device. The review panel was Neurology.

FDA logged the submission as received on Jun 23, 2025. The decision came 424 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Matap Ii, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under DEN250026?

DEN250026 is the FDA 510(k) for Avulux, submitted by Matap Ii, LLC. FDA's decision date was Aug 21, 2026, under product code QEO (Light Attenuation Lenses For Migraine-Associated Light Sensitivity).

Who makes the Avulux?

Matap Ii, LLC, based in Aventura, FL, is the applicant of record for DEN250026.

How long did the DEN250026 review take?

FDA received the submission on Jun 23, 2025 and issued its decision on Aug 21, 2026, 424 days later.

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