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Sanhe Jumei Technology Co.,ltd: FDA-registered device maker in Sanhe Hebei, China, 4 510(k) clearances

Name: Sanhe Jumei Technology Co.,ltd FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Sanhe Jumei Technology Co.,ltd is registered with the FDA (registration 3031233197) in Sanhe Hebei, China. It lists 12 device types. The FDA files 4 510(k) clearances under its listings, the newest dated September 17, 2024. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3031233197
Address: 001, 1002, 1003, Building A1, Modern Service Industrial Park, Sanhe Hebei, China, 065200
Owner or operator: Sanhe Jumei Technology Co.,Ltd (10090547)
Roles: Exporter to the US, Manufacturer
First device listed: May 21, 2024
Registered through: 2026
Brand names listed: CO2 Fractional Laser System,Z121,Z131,Z131pro,Z190,Z190A;, CO2 Laser Therapy Systems,Z131,Z131Pro,Z100,Z121,Z190,Z190A, Diode Laser Hair Removal System,Z820,Z860,Z840,Z870,Z890;, Diode Laser Hair Removal System,Z890B,Z890C,Z890E, HIEMT Body Sculpting & Muscle Building System,Z950,Z900,Z940,Z940Pro,W960A,W970, Hydrogen Oxygen Small Bubble System,Z400, Lipo Laser System,W100C,W180,W180A, Long Pluse ND-YAG Alexandrite Laser Hair Removal System, and more

Devices it lists

Device	Product code	Class	Role	Source
Apparatus, Roller	KJB	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Energy Based Device For Treatment Of Tattoos	QHF	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers	PZL	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Gas, Laser Generating	NXF	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Laser Assisted Lipolysis	ORK	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Light Based Over-The-Counter Hair Removal	OHT	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Marker, Skin	FZZ	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Powered Laser Surgical Instrument	GEX	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Powered Laser Surgical Instrument With MicrobeamFractional Output	ONG	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Powered Microneedle Device	QAI	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Powered Surgical Instrument For Improvement In The Appearance Of Cellulite	OUP	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Stimulator, Muscle, Powered, For Muscle Conditioning	NGX	2	Exporter to the US, 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
September 17, 2024	K242186	Neo Sculptor (OF-NEO001)	NGX	Substantially Equivalent	Ofan Intelligent Technology (Guangzhou) Co. , Ltd.	accessdata.fda.gov
December 7, 2017	K172908	Q-Switched Nd:YAG Laser System	GEX	Substantially Equivalent	Ami, Inc.	accessdata.fda.gov
July 6, 2017	K162398	CO2 Laser Therapy Systems	ONG	Substantially Equivalent	Beijing Sincoheren Science and Technology Development Co.	accessdata.fda.gov
June 16, 2017	K162659	Diode Laser Hair Removal System	GEX	Substantially Equivalent	Shandong Huamei Technology Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated September 17, 2024. 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.