510(k) Report

FDA applicant

Matap Ii, LLC

Aventura, FL1 decision2026–20260 recalls

FDA records 1 decision for Matap Ii, LLC (Aventura, FL) in 2026: 1 De Novo grant. All are in product code QEO (Light Attenuation Lenses For…). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, neurology panel, where it files most

How often FDA has decided Matap Ii, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2026

2026 (partial year): 1
2026high 1 (2026)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2026.

FIG. 1 — Matap Ii, LLC by year, 2026–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • QEOLight Attenuation Lenses For Migraine-Associated Light Sensitivity1decision

What has FDA decided for it lately?

The one decision as Matap Ii, LLC →