510(k) Report

FDA applicant

Seven Pyramid Ent Co., Ltd.

Taipei 11413, Taiwan, R.O.C., TW1 decision1994–19940 recalls

FDA records 1 decision for Seven Pyramid Ent Co., Ltd. (Taipei 11413, Taiwan, R.O.C., TW) 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 Seven Pyramid Ent Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Seven Pyramid Ent Co., Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Seven Pyramid 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 “Seven”

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