510(k) Report

FDA applicant

Baoding Te'Anzhou Electronic Technology Co., Ltd.

Baoding, CN2 decisions2025–20250 recalls

FDA records 2 decisions for Baoding Te'Anzhou Electronic Technology Co., Ltd. (Baoding, CN) in 2025: 2 510(k) clearances. All are in product code GEX (Powered Laser Surgical Instrument). Its devices cite 2 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 Baoding Te'Anzhou Electronic Technology Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2025

2025: 2
2025high 2 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2025.

FIG. 1 — Baoding Te'Anzhou Electronic Technology Co., Ltd. by year, 2025–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Baoding”

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