FDA applicant

Quantel Derma GmbH

Erlangen, DE2 decisions2009–20090 recalls

FDA records 2 decisions for Quantel Derma GmbH (Erlangen, DE) in 2009: 2 510(k) clearances. Most are in product codes GEX (Powered Laser Surgical Instrument) and ONG (Powered Laser Surgical Instrument With…). Its devices cite 9 predicates, 0 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 Quantel Derma GmbH’s devices, and how often a recall has named them.

FDA decisions per year

2in 2009

2009high 2 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Quantel Derma GmbH by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

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Other applicant names beginning “Quantel”

FDA records each applicant name separately; these may or may not be the same firm.

Quantel Medical 33 Quantel S.A. 2

Quantel Derma GmbH

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Quantel”