Hebei Tuosite Technology Co., Ltd.
Registered establishment in Shijiazhuang, Hebei, China. 14 device types.
Hebei Tuosite Technology Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Marker, Skin, Laser, Comb, Hair and 12 other device types. Its earliest product listing with the FDA dates from 2025.
Registration
| Registered name | HEBEI TUOSITE TECHNOLOGY CO.,LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3043149902 |
| FEI number | 3043149902 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 河北拓思特科技有限公司 |
|---|---|
| Source | Hong Kong company register lookup |
Location
| City | Shijiazhuang |
|---|---|
| Province | Hebei |
| Address | Room 2911, Tower A, MixC Mall, Qiaoxi District, |
| Postal code | 050000 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Acetylcholine Chloride, Specific Reagent For Pseudo Cholinesterase | Class 1 | Fractional CO2 Laser System Machine:TSLA05,TSLA06,TSLA07,TSLA08 | 2025 | 1 |
| Device, Pressure Applying | Class 1 | AN-T001,AS8008,AS9002, V39,V687,V9,V10, RF Cavitation machine:A52,B52,C52,A56,A57,B56,B57,M8+5S, BAT-3S+, | 2025 | 36 |
| Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers | Class 2 | Shockwave therapy:SW-01,SW-02,SW-03,SW-04,SW-05,SW-06,SW-07,SW-08 | 2025 | 6 |
| Gas, Laser Generating | Class 1 | Picosecond Laser Machine:TSLA09,TSLA10,TSLA11,TSLA12 | 2025 | 17 |
| Guide, Needle, Surgical | Class 1 | Rf Microneedling Machine:SPA1,SPA2,SPA3,M8,M9 | 2025 | 32 |
| High Intensity Focused Ultrasound System For Peripheral Neural Tissue Ablation | Class 2 | 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, | 2025 | 2 |
| Laser, Comb, Hair | Class 2 | Skin analyzer machine:SA1,SA2,SA12, Hair Regrowth Machine:H21,H22,H23,H24,H25,H26,H27,HS772,HR68,HR67,HR72 | 2025 | 30 |
| Marker, Skin | Class 1 | Facial Spa Oxygen Hydro Facial Beauty System:SPA4,SPA5,SPA6,SPA10E,H2,H3,WO5X,NV-W04X,NV-WX600,SPA9,DEP2, Body analyzer machine:GS6.5C,GS7,GS6.7 | 2025 | 55 |
| Massager, Therapeutic, Electric | Class 1 | Laser slimming machine:TSLA13,G22,LA30-MIX, Plasma Beauty device:A66,B66,C66,D66,A26,PB-01,PB-02, EMS face:EMS11,EMS12,EMS13,EMS14,EMS15 | 2025 | 437 |
| Powered Laser Surgical Instrument | Class 2 | Dermatological Diode Laser Systems, Multi-functional 980 1470 Diode Laser Machine:TKL-01,TKL-02, Diode Laser Hair Removal System:TSLA01,TSLA02,TSLA03,TSLA04 | 2025 | 92 |
| Powered Surgical Instrument For Improvement In The Appearance Of Cellulite | Class 2 | Multi-functional Cryolipolysis Slimming System:BRG80 2S,BRG804S,BRG80 6S,CTL80 5S,, CTM49,CTM27,CTM685S,XM278JK-CS01,JK-CS02,JK-CS03 | 2025 | 6 |
| Stimulator, Muscle, Powered, For Muscle Conditioning | Class 2 | Electronic Muscle Stimulator | 2025 | 66 |
| Stimulator, Nerve, Transcutaneous, For Pain Relief | Class 2 | Muscle Stimulation EMS Sculpting Machines:EMS1,EMS2,EMS3,EMS4,EMS5,EMS6,EMS7,EMS8,EMS9,EMS10 | 2025 | 32 |
| Unit, Syringe, Air And/Or Water | Class 1 | Air pressure suit:BR604,BR610,BR611,BR618,BR615,BR619PRO | 2025 | 56 |
Clearances
No clearance names Hebei Tuosite Technology Co., Ltd. as applicant. 2 are held by other companies and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K242186 | 2024-09-17 | NGX | Traditional | Ofan Intelligent Technology (Guangzhou) Co., Ltd. |
| K202257 | 2021-04-23 | GEX | Traditional | Zhuolu Jontelaser Manufacturing Technology Co., Ltd. |
From the Company
Published by the company on its own website, not by the FDA.
| Factory area | 40000 |
|---|---|
| Main products | Shade net, Shade sail, Vegetable mesh bag, Fruit mesh bag, Tarpaulins |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.