Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3031233199

FEI Number

3031233199

Entity Name

HEBEI LUFEN TECH CO., LIMITED

City/State/Country

Xingtai Hebei, CN

Establishment Address

Workshop No. 1, west side of Zhenxing Street and north side of, Kaifang Road, Weixian High-tech Industrial Development Zone,, Xingtai Hebei 065200, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Hebei Lufen Tech Co., Limited (Owner Number: 10090548)

Owner / Operator Contact Address

Workshop No. 1, west side of Zhenxing Street and north side of, Kaifang Road, Weixian High-tech Industrial Development Zone,, Xingtai, CN-HE 065200, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Multi-functional Cryolipolysis Slimming System IPL Intense Pulsed Light Machine Picosecond Laser Machine Q-switch Nd:YAG Laser Machine ELECTRONIC MUSCLE STIMULATOR Hyperbaric Oxygen Chamber Spa capsule alexandrite laser machine, Endolift laser fiber laser system. low-level green laser CO2 Laser Therapy Systems High Intensity Focused Ultrasound System Fractional RF Micro Golden Needle machine Shockwave therapy Diode Laser Hair Removal Systems Skin analyzer machine

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	Class 2	876.4300	2025-12-16
KNM	Device, Pressure Applying	Physical Medicine	Class 1	890.5765	2025-12-16
NXF	Gas, Laser Generating	General, Plastic Surgery	Class 1	878.4810	2025-12-16
IPF	Stimulator, Muscle, Powered	Physical Medicine	Class 2	890.5850	2025-12-16
FZZ	Marker, Skin	General, Plastic Surgery	Class 1	878.4660	2025-12-16
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2025-12-16
SGN	High Intensity Focused Ultrasound System For Peripheral Neural Tissue Ablation	Neurology	Class 2	882.4420	2025-12-16
QAI	Powered Microneedle Device	General, Plastic Surgery	Class 2	878.4430	2025-12-16
PZL	Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers	General, Plastic Surgery	Class 2	878.4685	2025-12-16
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2024-04-11
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	2025-12-16

Official Correspondent

Hongxin Liu

US Agent Details

Yuan Dan Email: service20210328@hotmail.com Phone: (805) 3513025

Related Public Records

Same Entity

Hebei Lufen Tech Co., Limited

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K172288	Wilson-Cook Medical Inc./Cook Endoscopy	Fusion OMNI Sphincterotome	2018-04-17
K030403	Cefar Medical AB	CEFAR REHAB 2 AND REHAB 2 PRO	2003-07-17
K231440	Shenzhen Roundwhale Technology Co. , Ltd.	Combo Electrotherapy Device	2023-11-03
K820884	Nitron Electronics	ELECTRICAL MUSCLE STIMULATOR	1982-04-29
K201958	Therasigma, LLC	ETD Family of Electrotherapy Devices	2020-08-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0005-2014	PhotoMedex, Inc.	2	The product is labeled in part "*Surgical Laser Technologies, Inc. Montgomeryville, PASLT Fiber Delivery SystemSterileNon-Pyrogenic**. The product is packaged in a flexible pouch and includes the following laser surgery accessories - SLT-SSRH 8, Catalog/Product Number 0041-3082; SLT-SSRH 11, Catalog/Product Number 0041-3112; SLT-SSRH 4-SMA, Catalog/Product Number 0042-0075; SLT-SSRH 5-SMA, Catalog/Product Number 0042-0076; SLT-SSRH 6-SMA, Catalog/Product Number 0042-0077; SLT-SSRH 7-SMA, Catalog/Product Number 0042-0078; SLT-SSRH 8-SMA, Catalog/Product Number 0042-0079; SLT-SSRH 9-SMA, Catalog/Product Number 0041-4931; and SLT-SSRH 10-SMA, Catalog/Product Number 0042-0081. Indicated for the incision, excision, coagulations, and vaporization of soft tissue.
Z-0025-2018	Medtronic Navigation, Inc.	2	VCLAS (Visualase Cooled Laser Ablation System) Part Number: 9735559 Visualase Cooled Laser Applicator System 3mm Tip; Part Number: 9735560 Visualase Cooled Laser Applicator System 10mm Tip; Part Number: 9735561 Visualase Cooled Laser Applicator System 15mm Tip
Z-0028-2007	Lumenis Inc.	2	Lumenis brand DuoTome SideLite 550 Micron Delivery System; laser systems for ablating soft tissue. Catalog Number: 0641-800-01; Manufactured by Lumenis, Inc., 2400 Condensa Street, Santa Clara, CA
Z-0002-2008	Beckman Coulter Inc	1	FP1000 Cell Preparation System Software versions 1.1 & 1.2, Part Number 624922, for in vitro diagnostic use.
Z-0023-2013	Biomerieux Inc	1	PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the inoculation and streaking of Prepoured Media (PPM) with liquid microbiological samples.

Similar Registrations

Registration Number	Establishment Name	Location
3013526170	Jiangsu Vedkang Medical Science and Technology Co.,Ltd.	Changzhou Jiangsu, CN
1000121056	Boston Scientific Corporation	Coventry, RI, US
3002807310	Synergy Health Sterilisation UK Ltd	Berkshire Reading, GB
1320894	CONMED CORPORATION	Utica, NY, US
3014769442	Aomori Olympus Co., Ltd. Hirosaki Site	Hirosaki-shi Aomori, JP

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3031233199. Last updated year: 2026. Please use registration number 3031233199 when referencing this establishment in official correspondence.