510(k) Report

FDA applicant

Mt. Derm GmbH

Berlin, DE3 decisions2018–20240 recalls

FDA records 3 decisions for Mt. Derm GmbH (Berlin, DE) from 2018 to 2024: 3 510(k) clearances. All are in product code QAI (Powered Microneedle Device). Its devices cite 3 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, general and plastic surgery panel, where it files most

How often FDA has decided Mt. Derm GmbH’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2018: 12019: 12024: 1
2018high 1 (2018) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Mt. Derm GmbH by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • QAIPowered Microneedle Device3decisions

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 times; 1 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.

  • K180778Exceed Microneedling DeviceMt. Derm GmbH · 20184cite it
  • K182407Exceed Microneedling deviceMt. Derm GmbH · 20192cite it

What has FDA decided for it lately?

  • K233709Exceed UnlimitedMt. Derm GmbH · 2024
  • K182407Exceed Microneedling deviceMt. Derm GmbH · 2019
  • K180778Exceed Microneedling DeviceMt. Derm GmbH · 2018

All 3 as Mt. Derm GmbH →