510(k) Report

FDA applicant

Virulite, LLC

Irvine, CA1 decision2012–20120 recalls

FDA records 1 decision for Virulite, LLC (Irvine, CA) in 2012: 1 De Novo grant. All are in product code OKJ (Light Based Treatment For Cold Sores Herpes…). 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 Virulite, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2012: 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 — Virulite, 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?

  • OKJLight Based Treatment For Cold Sores Herpes Simplex Virus-11decision

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • DEN090012Virulite Cold Sore MachineVirulite, LLC · 20121cites it

What has FDA decided for it lately?

  • DEN090012Virulite Cold Sore MachineVirulite, LLC · 2012

The one decision as Virulite, LLC →