Data / Medical devices / China / Risu Medical Technology Co., Ltd.
Risu Medical Technology Co., Ltd.: FDA-registered device maker in Xianyang Shaanxi, China, 2 510(k) clearances
Risu Medical Technology Co., Ltd. is registered with the FDA (registration 3044905918) in Xianyang Shaanxi, China. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated October 23, 2025. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3044905918
- Address
- Rm 201, Bldg 11, Western Cloud Valley (Phase III), the intersection of Kangding Road and Tongwen Road, Fengxi New City of Xixian New Area, Xianyang Shaanxi, China, 712000
- Owner or operator
- RiSu Medical Technology Co., Ltd. (10095425)
- Roles
- Manufacturer
- First device listed
- March 11, 2026
- Registered through
- 2026
- Brand names listed
- Cold Laser Therapy Device, Deep Tissue Laser Therapy System, Diode Laser Therapy System (DT47-BI, DT35-BI, DT29-BI, DT210-BI, DT37-BI, DT52-BI, DT49-BI), Diode laser device, High Power Laser Therapy (HPLT) System, Laser Physical Therapy System, Picosecond Laser Device
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Lamp, Infrared, Therapeutic Heating | ILY | 2 | Manufacturer | accessdata.fda.gov |
| Powered Laser Surgical Instrument | GEX | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 23, 2025 | K252345 | Picosecond Laser Device (PF131-BI) | GEX | Substantially Equivalent | Risu Medical Technology Co., Ltd. | accessdata.fda.gov |
| June 27, 2025 | K251329 | Diode laser device (RF3120-BI) | GEX | Substantially Equivalent | Risu Medical Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated October 23, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.