Data / Medical devices / China / Hebei Lufen Tech Co., Limited

Hebei Lufen Tech Co., Limited: FDA-registered device maker in Xingtai Hebei, China, 2 510(k) clearances

Name: Hebei Lufen Tech Co., Limited FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Hebei Lufen Tech Co., Limited is registered with the FDA (registration 3031233199) in Xingtai Hebei, China. It lists 12 device types. The FDA files 2 510(k) clearances under its listings, the newest dated September 5, 2021. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3031233199
Address: Workshop No. 1, west side of Zhenxing Street and north side of Kaifang Road, Weixian High-tech Industrial Development Zone, Xingtai Hebei, China, 065200
Owner or operator: Hebei Lufen Tech Co., Limited (10090548)
Roles: Contract manufacturer, Contract sterilizer, Manufacturer
First device listed: April 11, 2024
Registered through: 2026
Brand names listed: CO2 Laser Therapy Systems, Diode Laser Hair Removal Systems, ELECTRONIC MUSCLE STIMULATOR, EMSfacial machine, Electranic Muscle Stimulator:AST-300A, AST-300, Fractional RF Micro Golden Needle machine, High Intensity Focused Ultrasound System, Hyperbaric Oxygen Chamber Spa capsule and more

Devices it lists

Device	Product code	Class	Role	Source
Device, Pressure Applying	KNM	1	Manufacturer	accessdata.fda.gov
Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	LXG	1	Manufacturer	accessdata.fda.gov
Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers	PZL	2	Manufacturer	accessdata.fda.gov
Gas, Laser Generating	NXF	1	Manufacturer	accessdata.fda.gov
High Intensity Focused Ultrasound System For Peripheral Neural Tissue Ablation	SGN	2	Manufacturer	accessdata.fda.gov
Marker, Skin	FZZ	1	Manufacturer	accessdata.fda.gov
Massager, Therapeutic, Electric	ISA	1	Manufacturer	accessdata.fda.gov
Powered Laser Surgical Instrument	GEX	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Powered Microneedle Device	QAI	2	Manufacturer	accessdata.fda.gov
Stimulator, Muscle, Powered, For Muscle Conditioning	NGX	2	Contract sterilizer, Manufacturer	accessdata.fda.gov
Stimulator, Nerve, Transcutaneous, Over-The-Counter	NUH	2	Manufacturer	accessdata.fda.gov
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	KNS	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
September 5, 2021	K211736	Electronic Muscle Stimulator (Model: AST-300A, AST-300N, AST-300S, AST-300T, AST-300V, AST-300W)	NUH	Substantially Equivalent	Shenzhen Osto Technology Company Limited	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

Updated September 5, 2021. 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.