510(k) Report

FDA applicant

Sun Hing Optical Manufactory, Ltd.

Kwun Tong, Kowloon, Hong Kong, HK1 decision1995–19950 recalls

FDA records 1 decision for Sun Hing Optical Manufactory, Ltd. (Kwun Tong, Kowloon, Hong Kong, HK) in 1995: 1 510(k) clearance. All are in product code HQZ (Frame, Spectacle). 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 Sun Hing Optical Manufactory, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Sun Hing Optical Manufactory, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Sun Hing Optical Manufactory, Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Sun Hing Optical Manufactory, 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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