510(k) Report

FDA applicant

Refine USA, LLC

Jacksonville Beach, FL2 decisions2012–20200 recalls

FDA records 2 decisions for Refine USA, LLC (Jacksonville Beach, FL) from 2012 to 2020: 2 510(k) clearances. Most are in product codes QAI (Powered Microneedle Device) and ONQ (Electrosurgical Coagulation For Aesthetic). Its devices cite 2 predicates, 0 of them its own earlier devices. 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 Refine USA, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2012: 12020: 1
2012high 1 (2012) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2012.

FIG. 1 — Refine USA, LLC by year, 2012–2026Sources: 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
  • ONQElectrosurgical Coagulation For Aesthetic1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K192138Rejuvapen NXTRefine USA, LLC · 2020
  • K112334Vein-Gogh InstrumentRefine USA, LLC · 2012

All 2 as Refine USA, LLC →