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Beijing Sincoheren Science & Technology Development Co., Ltd: FDA-registered device maker in Bejing Beijing, China, 6 510(k) clearances

Name: Beijing Sincoheren Science & Technology Development Co., Ltd FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Beijing Sincoheren Science & Technology Development Co., Ltd is registered with the FDA (registration 3006555617) in Bejing Beijing, China. It lists 5 device types. The FDA files 6 510(k) clearances under its listings, the newest dated October 19, 2023. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3006555617
Address: 1-23, 10th Floor, Building 1, No.43 Xizhimen North Street, Haidian District, Bejing Beijing, China, 100044
Owner or operator: Beijing Sincoheren Science and TechnologyDevelopment Co., Lt (10043830)
Roles: Manufacturer, Repackager or relabeler
First device listed: March 26, 2013
Registered through: 2026
Brand names listed: CO2 Laser Therapy Systems, Model Monaliza-5, Diode Laser Therapy Systems, Model SDL-B, IPL Therapy System, Model SMQ-NK, IPL Therapy System, Model SMQ-NYC, LED Spectrum therapy instrument, Radio Frequency System

Devices it lists

Device	Product code	Class	Role	Source
Electrosurgical, Cutting & Coagulation & Accessories	GEI	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Lamp, Infrared, Therapeutic Heating	ILY	2	Manufacturer	accessdata.fda.gov
Powered Laser Surgical Instrument	GEX	2	Manufacturer	accessdata.fda.gov
Powered Laser Surgical Instrument With MicrobeamFractional Output	ONG	2	Manufacturer	accessdata.fda.gov
Powered Light Based Non-Laser Surgical Instrument With Thermal Effect	ONF	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
October 19, 2023	K231749	Radio Frequency System	GEI	Substantially Equivalent	Shenzhenshi Sincoheren S&T Development Co., Ltd.	accessdata.fda.gov
September 20, 2023	K231894	LED Spectrum therapy instrument	GEX	Substantially Equivalent	Shenzhenshi Sincoheren S&T Development Co., Ltd.	accessdata.fda.gov
July 6, 2017	K162398	CO2 Laser Therapy Systems	ONG	Substantially Equivalent	Beijing Sincoheren Science and Technology Development Co.	accessdata.fda.gov
February 2, 2017	K163123	Q-Switched Nd:YAG Laser Therapy Systems	GEX	Substantially Equivalent	Beijing Sincoheren Science and Technology Development Co.	accessdata.fda.gov
February 9, 2016	K152898	DIODE LASER THERAPY SYSTEMS	GEX	Substantially Equivalent	Beijing Sincoheren Science and Tech. Development Co., Ltd.	accessdata.fda.gov
February 11, 2013	K123435	IPL THERAPY SYSTEM	ONF	Substantially Equivalent	Beijing Sincoheren S&T Development Co, Ltd.	accessdata.fda.gov

Compare with other makers

Updated October 19, 2023. 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.