510(k) Report

FDA applicant

Harpo Industries

Holland, NL1 decision1994–19940 recalls

FDA records 1 decision for Harpo Industries (Holland, NL) in 1994: 1 510(k) clearance. All are in product code LEJ (Booth, Sun Tan). 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 Harpo Industries’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Harpo Industries since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Harpo Industries 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?

  • LEJBooth, Sun Tan1decision

Who builds on its devices?

Later devices cite its devices 2 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.

  • K944015Harpo Sunbed, Sun Tanning MachineHarpo Industries · 19942cite it

What has FDA decided for it lately?

  • K944015Harpo Sunbed, Sun Tanning MachineHarpo Industries · 1994

The one decision as Harpo Industries →