Beijing Sanhe Laser Co., Ltd.
Registered establishment in Beijing, China. 2 device types.
Beijing Sanhe Laser Co., Ltd. is an exporter holding a current FDA establishment registration. The registration covers Powered Laser Surgical Instrument, Stimulator, Muscle, Powered, For Muscle Conditioning. Its earliest product listing with the FDA dates from 2026.
Registration
| Registered name | BEIJING SANHE LASER CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3048246437 |
| FEI number | 3048246437 |
| Establishment type | Exporter |
Location
| City | Beijing |
|---|---|
| Province | Beijing |
| Address | Room 211, 2nd Floor, 101, Building 7, No. 1 Courtyard, Caida Third Street |
| Postal code | 101300 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Powered Laser Surgical Instrument | Class 2 | Cryojet Plus (SHE-ACP001-1), LumiGlam Laser System (SHE-LSP601-3), Diode Laser Hair Removal System(P-808/P-808L/P-808S/P-808W), Q-Switched Nd:YAG Laser (SHE-LSP101-1), CO2 Laser Therapy Systems (SHE-LSP003-1) | 2026 | 92 |
| Stimulator, Muscle, Powered, For Muscle Conditioning | Class 2 | HI-EMT MAGSHAPE(SHE-MSP003/SHE-MSP001/SHE-MSP002) | 2026 | 66 |
Clearances
No clearance names Beijing Sanhe Laser Co., Ltd. as applicant. 6 are held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K260690 | 2026-06-04 | GEX | Traditional | Beijing Sano Laser S&T Development Co., Ltd. |
| K250936 | 2025-06-12 | GEX | Traditional | Beijing Sano Laser S&T Development Co., Ltd. |
| K242941 | 2025-01-27 | GEX | Traditional | Beijing Sano Laser S&T Development Co., Ltd. |
| K233416 | 2024-02-06 | GEX | Traditional | Beijing Sano Laser S&T Development Co., Ltd. |
| K230024 | 2023-09-06 | NGX | Traditional | Beijing Sano Laser S&T Development Co., Ltd. |
| K191970 | 2020-04-06 | GEX | Traditional | Beijing Sano Laser S&T Development Co., Ltd. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2005 |
|---|---|
| Employees | 200+ |
| Factory area | 18000 m2 |
| Main products | 808nm diode laser hair removal, Cryolipolysis slimming, Picosecond laser tattoo removal, EMS muscle sculpting, Fractional CO2 laser |
| Certifications | CE (TUV), ISO 13485 (TUV), FDA |
| Export markets | 40+ countries: USA, UK, Australia, Spain, Korea, Japan, Russia, India, Dubai |
| OEM and ODM | Offered |
Nearby Manufacturers
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.