FDA applicant

Asclepion Laser Technologies GmbH

Jena, DE29 decisions2004–20260 recalls

FDA records 29 decisions for Asclepion Laser Technologies GmbH (Jena, DE) from 2004 to 2026: 29 510(k) clearances. Most are in product codes GEX (Powered Laser Surgical Instrument) and GCJ (Laparoscope, General & Plastic Surgery). Since 2016 its 510(k)s took a median of 185 days from receipt to decision, against 90 for FDA’s reviews in the same codes and years. Its devices cite 38 predicates, 18 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 Asclepion Laser Technologies GmbH’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2007high 4 (2015) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Asclepion Laser Technologies GmbH by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Asclepion Laser Technologies 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 “Asclepion”

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

Asclepion-Meditec AG 5

Asclepion Laser Technologies GmbH

Which product codes does it file in?

How long do its 510(k) reviews take?

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 “Asclepion”