FDA applicant

Asclepion-Meditec AG

Irvine, CA5 decisions2000–20020 recalls

FDA records 5 decisions for Asclepion-Meditec AG (Irvine, CA) from 2000 to 2002: 5 510(k) clearances. Most are in product codes GEX (Powered Laser Surgical Instrument) and HQC (Unit, Phacofragmentation). Its devices cite 10 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 Asclepion-Meditec AG’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Asclepion-Meditec AG since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Asclepion-Meditec”

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

Asclepion Laser Technologies GmbH 29

Asclepion-Meditec AG

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 “Asclepion-Meditec”