510(k) Report

FDA applicant

Kbl GmbH

Dernbach, DE2 decisions2016–20190 recalls

FDA records 2 decisions for Kbl GmbH (Dernbach, DE) from 2016 to 2019: 2 510(k) clearances. All are in product code LEJ (Booth, Sun Tan). Its devices cite 1 predicate, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Kbl AG”.

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 Kbl GmbH’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2016: 12019: 1
2016high 1 (2016) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

FIG. 1 — Kbl GmbH by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Kbl GmbH’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • LEJBooth, Sun Tan2decisions

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K151962KBL Sunlamp Products (= Device Bundling name)Kbl AG · 20161cites it

What has FDA decided for it lately?

  • K191881KBL 7000 alpha hybridSun, KBL 7900 alpha hybridSun, KBL 8000 alpha hybridSunKbl GmbH · 2019
  • K151962KBL Sunlamp Products (= Device Bundling name)Kbl AG · 2016

The one decision as Kbl GmbH →The one decision as Kbl AG →