510(k) Report

FDA applicant

Advanced Technology Laser Co., Ltd.

Shanghai, CN5 decisions2009–20140 recalls

FDA records 5 decisions for Advanced Technology Laser Co., Ltd. (Shanghai, CN) from 2009 to 2014: 5 510(k) clearances. All are in product code GEX (Powered Laser Surgical Instrument). Its devices cite 4 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 Advanced Technology Laser Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2009: 22010: 22014: 1
2009high 2 (2009) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Advanced Technology Laser Co., Ltd. by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Advanced Technology Laser Co., 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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