FDA applicant

Humanoptics AG

Erlangen1 decision2018–20180 recalls

FDA records 1 decision for Humanoptics AG (Erlangen) in 2018: 1 original PMA approval. All are in product code QBT (Artificial Iris). 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, ophthalmic panel, where it files most

How often FDA has decided Humanoptics AG’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2018high 1 (2018) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

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

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Humanoptics AG

Which product codes does it file in?

What has FDA decided for it lately?