510(k) Report

FDA applicant

Bemer Int AG

Triesen, LI4 decisions2017–20231 recall

FDA records 4 decisions for Bemer Int AG (Triesen, LI) from 2017 to 2023: 4 510(k) clearances. Most are in product codes NGX (Stimulator, Muscle, Powered, For Muscle…) and OHS (Light Based Over The Counter Wrinkle Reduction). Since 2016 its 510(k)s took a median of 149 days from receipt to decision, against 105 for FDA’s reviews in the same codes and years. Its devices cite 8 predicates, 3 of them its own earlier devices. 1 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 Bemer Int AG’s devices, and how often a recall has named them.

FDA decisions per year

2in 2023

2017: 12021: 12023: 2
2017high 2 (2023) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

1in 2021

2021: 1
2017high 1 (2021) · low 0 (2017)2026

Class I Class II/III not classified

FIG. 1 — Bemer Int AG by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • NGXStimulator, Muscle, Powered, For Muscle Conditioning3decisions
  • OHSLight Based Over The Counter Wrinkle Reduction1decision

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 149 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 105 days; 2 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 8 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 11 times; 3 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.

  • K151834BEMER Classic Set, BEMER Pro-SetBemer Int AG · 20175cite it
  • K210174BEMER Therapy Systems, BEMER Classic Set, BEMER Pro-SetBemer Int AG · 20214cite it
  • K223919B.Light Clear Evo and B.Light Restore EvoBemer Int AG · 20232cite it

What has FDA decided for it lately?

  • K223919B.Light Clear Evo and B.Light Restore EvoBemer Int AG · 2023
  • K231368Bemer Therapy System EvoBemer Int AG · 2023
  • K210174BEMER Therapy Systems, BEMER Classic Set, BEMER Pro-SetBemer Int AG · 2021
  • K151834BEMER Classic Set, BEMER Pro-SetBemer Int AG · 20171 recall

All 4 as Bemer Int AG →

What has been recalled?

1 recall linked to its devices; the latest:

  • K151834Bemer-Set/ Pro-Set for the following models: REF. 410201 (BEMER Pro-Set), REF. 420201…Jan 13, 2021Class II