Data / Medical devices / China / Beijing Sanhe Tech Co., Ltd.
Beijing Sanhe Tech Co., Ltd.: FDA-registered device maker in Beijing, China, 5 510(k) clearances
Beijing Sanhe Tech Co., Ltd. is registered with the FDA (registration 3017173524) in Beijing, China. It lists 2 device types. The FDA files 5 510(k) clearances under its listings, the newest dated June 12, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3017173524
- Address
- Room 7-204, No.1, Caida 3rd Street, Nancai Town, Shunyi District, Beijing, China, Beijing, China, 101300
- Owner or operator
- Beijing Sanhe Tech Co., Ltd. (10086795)
- Roles
- Manufacturer
- First device listed
- December 13, 2022
- Registered through
- 2026
- Brand names listed
- CO2 Laser Therapy Systems, Cryoiet Plus(SHE-ACP001-1), HI-EMT MAGSHAPE, Powered Laser Surgical Instrument, Q-Switched Nd:YAG Laser SHE-LSP101-1
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Powered Laser Surgical Instrument | GEX | 2 | Manufacturer | accessdata.fda.gov |
| Stimulator, Muscle, Powered, For Muscle Conditioning | NGX | 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 |
|---|---|---|---|---|---|---|
| June 12, 2025 | K250936 | Q-Switched Nd:YAG Laser (SHE-LSP101-1) | GEX | Substantially Equivalent | Beijing Sano Laser S&T Development Co.,Ltd | accessdata.fda.gov |
| January 27, 2025 | K242941 | CO2 Laser Therapy Systems (SHE-LSP003-1) | GEX | Substantially Equivalent | Beijing Sano Laser S&T Development Co.,Ltd | accessdata.fda.gov |
| February 6, 2024 | K233416 | Cryojet Plus (SHE-ACP001-1) | GEX | Substantially Equivalent | Beijing Sano Laser S&T Development Co.,Ltd | accessdata.fda.gov |
| September 6, 2023 | K230024 | HI-EMT MAGSHAPE | NGX | Substantially Equivalent | Beijing Sano Laser S&T Development Co.,Ltd | accessdata.fda.gov |
| April 6, 2020 | K191970 | Diode Laser Hair Removal System | GEX | Substantially Equivalent | Beijing Sano Laser S&T Development Co.,Ltd | accessdata.fda.gov |
Compare with other makers
- All makers of Powered Laser Surgical Instrument
- All makers of Stimulator, Muscle, Powered, For Muscle Conditioning
Updated June 12, 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.