510(k) Report

FDA applicant

Waldmann Lighting

Deerfield, IL2 decisions1984–20060 recalls

FDA records 2 decisions for Waldmann Lighting (Deerfield, IL) from 1984 to 2006: 2 510(k) clearances. Most are in product codes FTD (Lamp, Surgical) and KGL (Cabinet, Phototherapy (Puva)). Its devices cite 1 predicate, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Waldmann Lighting Co.”.

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 Waldmann Lighting’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Waldmann Lighting since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Waldmann Lighting by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FTDLamp, Surgical1decision
  • KGLCabinet, Phototherapy (Puva)1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

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.

  • K841795UV 8001K, Puva 800, Puva 180/200 1000Waldmann Lighting Co. · 19841cites it

What has FDA decided for it lately?

  • K053364Halux Iris Examination and Surgical LampWaldmann Lighting · 2006
  • K841795UV 8001K, Puva 800, Puva 180/200 1000Waldmann Lighting Co. · 1984

The one decision as Waldmann Lighting →The one decision as Waldmann Lighting Co. →