Risu Medical Technology Co., Ltd.
Registered establishment in Xianyang, Shaanxi, China. 2 device types, 2 clearances.
Risu Medical Technology Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Powered Laser Surgical Instrument, Lamp, Infrared, Therapeutic Heating. Its earliest product listing with the FDA dates from 2026.
2device types registered with the FDA
2510(k) clearances
Registration
| Registered name | RISU MEDICAL TECHNOLOGY CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3044905918 |
| FEI number | 3044905918 |
| Establishment type | Manufacturer |
Location
| City | Xianyang |
|---|---|
| Province | Shaanxi |
| Address | Rm 201, Bldg 11, Western Cloud Valley (Phase III), the intersection of Kangding Road and Tongwen Road, Fengxi |
| Postal code | 712000 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Lamp, Infrared, Therapeutic Heating | Class 2 | Cold Laser Therapy Device, Diode Laser Therapy System (DT47-BI, DT35-BI, DT29-BI, DT210-BI, DT37-BI, DT52-BI, DT49-BI), Deep Tissue Laser Therapy System, Laser Physical Therapy System, High Power Laser Therapy (HPLT) System | 2026 | 235 |
| Powered Laser Surgical Instrument | Class 2 | Diode laser device, Picosecond Laser Device | 2026 | 92 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K252345 | 2025-10-23 | GEX | Traditional | This company |
| K251329 | 2025-06-27 | GEX | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Employees | 300+ R&D engineers |
|---|---|
| Factory area | 3000+ square meters |
| Main products | Picosecond laser systems, Q-switched laser systems, Diode laser systems, Dual-wavelength laser systems, Handheld laser devices |
| Certifications | National High-Tech Enterprise, National Design Patents (4 devices) |
| Export markets | International (16 language versions) |
| OEM and ODM | Offered |
Nearby Manufacturers
| Manufacturer | Device types |
|---|---|
| Sinol Dental Limited | 5 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.