510(k) Report

FDA applicant

Bellus Medical, LLC

Dallas, TX1 decision2018–20180 recalls

FDA records 1 decision for Bellus Medical, LLC (Dallas, TX) in 2018: 1 De Novo grant. All are in product code QAI (Powered Microneedle Device). 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, general and plastic surgery panel, where it files most

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

FDA decisions per year

1in 2018

2018: 1
2018high 1 (2018) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Bellus Medical, LLC by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • QAIPowered Microneedle Device1decision

Who builds on its devices?

Later devices cite its devices 9 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • DEN160029SkinPen Precision SystemBellus Medical, LLC · 20189cite it

What has FDA decided for it lately?

  • DEN160029SkinPen Precision SystemBellus Medical, LLC · 2018

The one decision as Bellus Medical, LLC →