510(k) Report

FDA applicant

Neurolumen, LLC

Oklahoma City, OK2 decisions2009–20150 recalls

FDA records 2 decisions for Neurolumen, LLC (Oklahoma City, OK) from 2009 to 2015: 2 510(k) clearances. All are in product code ILY (Lamp, Infrared, Therapeutic Heating). Its devices cite 4 predicates, 1 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, physical medicine panel, where it files most

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

FDA decisions per year

1in 2015

2009: 12015: 1
2009high 1 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Neurolumen, LLC by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • ILYLamp, Infrared, Therapeutic Heating2decisions

Whose devices does it build on?

Its devices cite 4 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K082223Neutrolumenpn System, Model 1000Neurolumen, LLC · 20091cites it

What has FDA decided for it lately?

  • K142025Neurolumen PN-1000Neurolumen, LLC · 2015
  • K082223Neutrolumenpn System, Model 1000Neurolumen, LLC · 2009

All 2 as Neurolumen, LLC →