510(k) Report

FDA applicant

Three Leaves Industrial Co., Ltd.

Taipei, Taiwan, R.O.C., CN1 decision1994–19940 recalls

FDA records 1 decision for Three Leaves Industrial Co., Ltd. (Taipei, Taiwan, R.O.C., CN) in 1994: 1 510(k) clearance. All are in product code HQY (Sunglasses (Non-Prescription Including…). 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 Three Leaves Industrial Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Three Leaves Industrial Co., Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Three Leaves Industrial Co., Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Three”

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