Beijing Sincoheren Science & Technology Development Co., Ltd.
Registered establishment in Bejing, Beijing, China. 5 device types.
Beijing Sincoheren Science & Technology Development Co., Ltd. is a repacker / relabeller holding a current FDA establishment registration. The registration covers Powered Laser Surgical Instrument, Lamp, Infrared, Therapeutic Heating and 3 other device types. Its earliest product listing with the FDA dates from 2013.
Registration
| Registered name | BEIJING SINCOHEREN SCIENCE & TECHNOLOGY DEVELOPMENT CO., LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3006555617 |
| FEI number | 3006555617 |
| Establishment type | Repacker / relabeller, Manufacturer |
Location
| City | Bejing |
|---|---|
| Province | Beijing |
| Address | 1-23, 10th Floor, Building 1, No.43 Xizhimen North Street, Haidian District |
| Postal code | 100044 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | Class 2 | Radio Frequency System | 2024 | 65 |
| Lamp, Infrared, Therapeutic Heating | Class 2 | LED Spectrum therapy instrument | 2024 | 235 |
| Powered Laser Surgical Instrument | Class 2 | LED Spectrum therapy instrument, Q-Switched Nd:YAG Laser Therapy Systems, Diode Laser Therapy Systems, CO2 Laser Therapy Systems | 2016 | 92 |
| Powered Laser Surgical Instrument With MicrobeamFractional Output | Class 2 | CO2 Laser Therapy Systems | 2017 | 12 |
| Powered Light Based Non-Laser Surgical Instrument With Thermal Effect | Class 2 | IPL Therapy System | 2013 | 31 |
Clearances
No clearance names Beijing Sincoheren Science & Technology Development Co., Ltd. as applicant. 6 are held by other companies 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 |
|---|---|---|---|---|
| K231749 | 2023-10-19 | GEI | Traditional | Shenzhenshi Sincoheren S&T Development Co., Ltd. |
| K231894 | 2023-09-20 | GEX | Traditional | Shenzhenshi Sincoheren S&T Development Co., Ltd. |
| K162398 | 2017-07-06 | ONG | Traditional | Beijing Sincoheren Science and Technology Development Co. |
| K163123 | 2017-02-02 | GEX | Traditional | Beijing Sincoheren Science and Technology Development Co. |
| K152898 | 2016-02-09 | GEX | Traditional | Beijing Sincoheren Science and Technology Development Co. |
| K123435 | 2013-02-11 | ONF | Traditional | Beijing Sincoheren S&T Development Co., Ltd. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 1999 |
|---|---|
| Factory area | 2000+ m² |
| Main products | IPL Laser systems, CO2 Laser equipment, Diode Laser hair removal, Q-Switched ND:YAG Laser, Cryolipolysis devices |
| Certifications | ISO13485, ISO, CE, FDA |
| Export markets | Europe, USA, Australia |
| OEM and ODM | Offered |
Nearby Manufacturers
| Manufacturer | Device types |
|---|---|
| Beijing Hongyisifang Radiation Technology Corp., Ltd. | 1 |
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.