510(k) Report

FDA applicant

Shenzhen Boyuan Intelligent Electronic Technology Co., Ltd.

Shenzhen, CN1 decision2021–20210 recalls

FDA records 1 decision for Shenzhen Boyuan Intelligent Electronic Technology Co., Ltd. (Shenzhen, CN) in 2021: 1 510(k) clearance. All are in product code ONF (Powered Light Based Non-Laser Surgical…). 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 Shenzhen Boyuan Intelligent Electronic Technology Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2021: 1
2021high 1 (2021) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

FIG. 1 — Shenzhen Boyuan Intelligent Electronic Technology Co., Ltd. by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • ONFPowered Light Based Non-Laser Surgical Instrument With Thermal Effect1decision

What has FDA decided for it lately?

  • K210119IPL Hair Removal Device (Model: KCA423)Shenzhen Boyuan Intelligent Electronic Technology Co., Ltd. · 2021

The one decision as Shenzhen Boyuan Intelligent Electronic Technology Co., Ltd. →