Hebei Lufen Tech Co., Limited
Registered establishment in Xingtai, Hebei, China. 12 device types.
Hebei Lufen Tech Co., Limited is a contract manufacturer holding a current FDA establishment registration. The registration covers Marker, Skin, Gas, Laser Generating and 10 other device types. Its earliest product listing with the FDA dates from 2024.
Registration
| Registered name | HEBEI LUFEN TECH CO., LIMITED |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3031233199 |
| FEI number | 3031233199 |
| Establishment type | Contract manufacturer, Contract steriliser, Manufacturer |
Chinese Registration
| Chinese legal name | 河北璐芬科技有限公司 |
|---|---|
| Source | Hong Kong company register lookup |
Location
| City | Xingtai |
|---|---|
| Province | Hebei |
| Address | Workshop No. 1, west side of Zhenxing Street and north side of |
| Postal code | 065200 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Device, Pressure Applying | Class 1 | IPL Intense Pulsed Light Machine | 2025 | 36 |
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | Class 1 | Skin analyzer machine | 2025 | 72 |
| Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers | Class 2 | Shockwave therapy | 2025 | 6 |
| Gas, Laser Generating | Class 1 | Q-switch Nd:YAG Laser Machine, Picosecond Laser Machine | 2025 | 17 |
| High Intensity Focused Ultrasound System For Peripheral Neural Tissue Ablation | Class 2 | High Intensity Focused Ultrasound System | 2025 | 2 |
| Marker, Skin | Class 1 | Hyperbaric Oxygen Chamber Spa capsule | 2025 | 55 |
| Massager, Therapeutic, Electric | Class 1 | EMSfacial machine, Tattoo Removal Machine | 2025 | 437 |
| Powered Laser Surgical Instrument | Class 2 | Diode Laser Hair Removal Systems, fiber laser system., low-level green laser, alexandrite laser machine, Endolift laser, CO2 Laser Therapy Systems | 2024 | 92 |
| Powered Microneedle Device | Class 2 | Fractional RF Micro Golden Needle machine | 2025 | 10 |
| Stimulator, Muscle, Powered, For Muscle Conditioning | Class 2 | Electronic Muscle Stimulator, NS EMS Muscle massager, Hiemt emslim machine,EMS8-1 EMS8-2 EMS8-3 EMS8-4 EMS8-5 EMS8-6 EMS8-7 EMS8-8 EMS10,EMS11,EMS12,E, Electranic Muscle Stimulator:AST-300A, AST-300 | 2026 | 66 |
| Stimulator, Nerve, Transcutaneous, Over-The-Counter | Class 2 | Electranic Muscle Stimulator:AST-300A, AST-300 | 2026 | 57 |
| Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | Class 2 | Multi-functional Cryolipolysis Slimming System | 2025 | 7 |
Clearances
No clearance names Hebei Lufen Tech Co., Limited 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 |
|---|---|---|---|---|
| K211736 | 2021-09-05 | NUH | Traditional | Shenzhen Osto Medical Technology Company Limited |
| K191970 | 2020-04-06 | GEX | Traditional | Beijing Sano Laser S&T Development Co., Ltd. |
Nearby Manufacturers
| Manufacturer | Device types |
|---|---|
| Ningjin Runboda Medical Protective Products Co., Ltd. | 8 |
| Kimlead Hygiene Products (Hebei) Co., Ltd. | 5 |
| Hebei Titans Hongsen Medical Technology Co., Ltd. | 3 |
| Hebei Grandeast Plastic Products Co Ltd | 1 |
| Hebei Hongtai Plastic Products Co., Ltd. | 1 |
| Hebei Handform Medical Products Co., Ltd. | 1 |
| Hebei Changsheng Plastic Products Co., Ltd. | 1 |
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.