510(k) Report

FDA applicant

Visco Vision, Inc.

Taoyuan City, TW12 decisions2015–20260 recalls

FDA records 12 decisions for Visco Vision, Inc. (Taoyuan City, TW) from 2015 to 2026: 12 510(k) clearances. All are in product code LPL (Lenses, Soft Contact, Daily Wear). Since 2016 its 510(k)s took a median of 131 days from receipt to decision, against 112 for FDA’s reviews in the same codes and years. Its devices cite 15 predicates, 9 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 Visco Vision, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2020

2015: 12016: 22017: 12018: 32019: 22020: 22026 (partial year): 1
2015high 3 (2018) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Visco Vision, Inc. by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Visco Vision, Inc.’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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