FDA applicant

Vizionfocus, Inc.

Miaoli County, TW5 decisions2018–20250 recalls

FDA records 5 decisions for Vizionfocus, Inc. (Miaoli County, TW) from 2018 to 2025: 5 510(k) clearances. All are in product code LPL (Lenses, Soft Contact, Daily Wear). Since 2016 its 510(k)s took a median of 111 days from receipt to decision, against 128 for FDA’s reviews in the same codes and years. Its devices cite 11 predicates, 3 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, ophthalmic panel, where it files most

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

FDA decisions per year

2in 2025

2018high 2 (2025) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

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

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Vizionfocus, Inc.

Which product codes does it file in?

How long do its 510(k) reviews take?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?