510(k) Report

FDA applicant

Risu Medical Technology Co., Ltd.

Fengxi New City Of Xixian New Area, CN2 decisions2025–20250 recalls

FDA records 2 decisions for Risu Medical Technology Co., Ltd. (Fengxi New City Of Xixian New Area, CN) in 2025: 2 510(k) clearances. All are in product code GEX (Powered Laser Surgical Instrument). Its devices cite 5 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 Risu Medical 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 — Risu Medical Technology Co., Ltd. by year, 2025–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • GEXPowered Laser Surgical Instrument2decisions

Whose devices does it build on?

Its devices cite 5 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K251329Diode laser device (RF3120-BI)Risu Medical Technology Co., Ltd. · 20252cite it

What has FDA decided for it lately?

  • K252345Picosecond Laser Device (PF131-BI)Risu Medical Technology Co., Ltd. · 2025
  • K251329Diode laser device (RF3120-BI)Risu Medical Technology Co., Ltd. · 2025

All 2 as Risu Medical Technology Co., Ltd. →