Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3043149902

FEI Number

3043149902

Entity Name

HEBEI TUOSITE TECHNOLOGY CO.,LTD

City/State/Country

Shijiazhuang Hebei, CN

Establishment Address

Room 2911, Tower A, MixC Mall, Qiaoxi District,, Shijiazhuang Hebei 050000, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Hebei Tuosite Technology Co.,Ltd (Owner Number: 10094850)

Owner / Operator Contact Address

Room 2911, Tower A, MixC Mall, Qiaoxi District,, Shijiazhuang, CN-HE 050000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Dermatological Diode Laser Systems Multi-functional 980 1470 Diode Laser Machine:TKL-01,TKL-02 Diode Laser Hair Removal System:TSLA01,TSLA02,TSLA03,TSLA04 AN-T001,AS8008,AS9002, V39,V687,V9,V10 RF Cavitation machine:A52,B52,C52,A56,A57,B56,B57,M8+5S, BAT-3S+, FUV1-7D,FUV2-7D,FUV3-7D,HIF2-1S,HIF2-2S,HIF3-1S,HIF3-2S,HIF4.5-1S High Intensity Focused Ultrasound System:FU100,FU200,FU250,FU300,FU400,FU3-1S,FU4.5-3S,FU3-4S,FU3-5S,FU-7D, Muscle Stimulation EMS Sculpting Machines:EMS1,EMS2,EMS3,EMS4,EMS5,EMS6,EMS7,EMS8,EMS9,EMS10 Rf Microneedling Machine:SPA1,SPA2,SPA3,M8,M9 Fractional CO2 Laser System Machine:TSLA05,TSLA06,TSLA07,TSLA08 Multi-functional Cryolipolysis Slimming System:BRG80 2S,BRG804S,BRG80 6S,CTL80 5S, CTM49,CTM27,CTM685S,XM278JK-CS01,JK-CS02,JK-CS03 Air pressure suit:BR604,BR610,BR611,BR618,BR615,BR619PRO

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2025-12-29
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2025-12-29
KNM	Device, Pressure Applying	Physical Medicine	Class 1	890.5765	2025-12-29
SGN	High Intensity Focused Ultrasound System For Peripheral Neural Tissue Ablation	Neurology	Class 2	882.4420	2025-12-29
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	Class 2	882.5890	2025-12-29
GDF	Guide, Needle, Surgical	General, Plastic Surgery	Class 1	878.4800	2025-12-29
DLI	Acetylcholine Chloride, Specific Reagent For Pseudo Cholinesterase	Clinical Toxicology	Class 1	862.3240	2025-12-29
OUP	Powered Surgical Instrument For Improvement In The Appearance Of Cellulite	General, Plastic Surgery	Class 2	878.4790	2025-12-29
ECB	Unit, Syringe, Air And/Or Water	Dental	Class 1	872.4565	2025-12-29

Official Correspondent

Xinxin Jia

US Agent Details

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

Related Public Records

Same Entity

Hebei Tuosite Technology Co.,Ltd

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
K083258	Dornier Medtech America, Inc.	MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE	2009-01-30
K201111	Candela Corporation	GentleMax Pro Plus	2020-05-26
K202758	Shangdong Huamei Technology Co., Ltd.	Nd: YAG Laser Therapy Systems HM-YL900	2020-11-16
K904068	Luxar Corp.	LUXAR MODEL LX-20 CO2 LASER	1991-04-15
K142225	CAO Group, Inc.	Pilot Elite Diode Laser	2014-09-12

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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3043149902. Last updated year: 2026. Please use registration number 3043149902 when referencing this establishment in official correspondence.