510(k) Report

FDA applicant

Yon'S Jay Enterprise Co.

Tainan, Taiwan, TW3 decisions1994–19950 recalls

FDA records 3 decisions for Yon'S Jay Enterprise Co. (Tainan, Taiwan, TW) from 1994 to 1995: 3 510(k) clearances. All are in product code HQY (Sunglasses (Non-Prescription Including…). No recall is linked to its devices.

FDA’s records also spell it “Yon'S Jay Enterprise Co., Ltd.”.

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 Yon'S Jay Enterprise Co.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Yon'S Jay Enterprise Co. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Yon'S Jay Enterprise Co. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Yon'S Jay Enterprise Co.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report