Data / Medical devices / China / Beijing Sanhe Laser Co., Ltd.
Beijing Sanhe Laser Co., Ltd.: FDA-registered device maker in Beijing, China, 6 510(k) clearances
Beijing Sanhe Laser Co., Ltd. is registered with the FDA (registration 3048246437) in Beijing, China. It lists 2 device types. The FDA files 6 510(k) clearances under its listings, the newest dated June 4, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3048246437
- Address
- Room 211, 2nd Floor, 101, Building 7, No. 1 Courtyard, Caida Third Street, Beijing, China, 101300
- Owner or operator
- Beijing Sanhe Laser Co., Ltd. (10096034)
- Roles
- Exporter to the US
- First device listed
- June 11, 2026
- Registered through
- 2026
- Brand names listed
- CO2 Laser Therapy Systems (SHE-LSP003-1), Cryojet Plus (SHE-ACP001-1), Diode Laser Hair Removal System(P-808/P-808L/P-808S/P-808W), HI-EMT MAGSHAPE(SHE-MSP003/SHE-MSP001/SHE-MSP002), LumiGlam Laser System (SHE-LSP601-3), Q-Switched Nd:YAG Laser (SHE-LSP101-1)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Powered Laser Surgical Instrument | GEX | 2 | Exporter to the US | accessdata.fda.gov |
| Stimulator, Muscle, Powered, For Muscle Conditioning | NGX | 2 | Exporter to the US | 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 4, 2026 | K260690 | LumiGlam Laser System (SHE-LSP601-3) | GEX | Substantially Equivalent | Beijing Sano Laser S&T Development Co.,Ltd | accessdata.fda.gov |
| 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 4, 2026. 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.