510(k) Report

FDA applicant

Sing Wah International Enterprises, Ltd.

Connaught, HK2 decisions1994–19940 recalls

FDA records 2 decisions for Sing Wah International Enterprises, Ltd. (Connaught, HK) in 1994: 2 510(k) clearances. Most are in product codes HOI (Spectacle, Magnifying) and 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 Sing Wah International Enterprises, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Sing Wah International Enterprises, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Sing Wah International Enterprises, Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • HOISpectacle, Magnifying1decision
  • HQYSunglasses (Non-Prescription Including Photosensitive)1decision

What has FDA decided for it lately?

  • K943613NILSing Wah International Enterprises, Ltd. · 1994
  • K943263NILSing Wah International Enterprises, Ltd. · 1994

All 2 as Sing Wah International Enterprises, Ltd. →