510(k) Report

FDA applicant

Long IN Time Ent. Co., Ltd.

Tainan Hsien, TW1 decision1997–19970 recalls

FDA records 1 decision for Long IN Time Ent. Co., Ltd. (Tainan Hsien, TW) in 1997: 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 Long IN Time Ent. Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Long IN Time Ent. Co., Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Long IN Time Ent. 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 “Long”

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