510(k) Report

FDA applicant

Duplex International Trading Limited

Hong Kong, CN2 decisions2022–20260 recalls

FDA records 2 decisions for Duplex International Trading Limited (Hong Kong, CN) from 2022 to 2026: 2 510(k) clearances. All are in product code OHS (Light Based Over The Counter Wrinkle Reduction). Its devices cite 3 predicates, 0 of them its own earlier devices. 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, general and plastic surgery panel, where it files most

How often FDA has decided Duplex International Trading Limited’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2022: 12026 (partial year): 1
2022high 1 (2022) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2022.

FIG. 1 — Duplex International Trading Limited by year, 2022–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Duplex International Trading Limited’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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