510(k) Report

FDA applicant

Yung Sheng Optical Co., Ltd.

Taichung City, TW10 decisions2013–20250 recalls

FDA records 10 decisions for Yung Sheng Optical Co., Ltd. (Taichung City, TW) from 2013 to 2025: 10 510(k) clearances. Most are in product codes LPL (Lenses, Soft Contact, Daily Wear) and MVN (Lens, Contact, (Disposable)). Since 2016 its 510(k)s took a median of 329 days from receipt to decision, against 185 for FDA’s reviews in the same codes and years. Its devices cite 12 predicates, 6 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 Yung Sheng Optical Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2013: 12014: 22015: 32022: 12023: 12024: 12025: 1
2013high 3 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

FIG. 1 — Yung Sheng Optical Co., Ltd. by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Yung Sheng Optical Co., Ltd.’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 “Yung”

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