FDA Registration
Active
🇨🇳 China
HEBEI LUFEN TECH CO., LIMITED
Reg #: 3031233199
·
FEI: 3031233199
·
Expires 2026
Products
11
Proprietary Names
17
Establishment Types
3
Classifications
11
Registration Details
- Registration Name
- HEBEI LUFEN TECH CO., LIMITED
- Registration Number
- 3031233199
- FEI Number
- 3031233199
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Workshop No. 1, west side of Zhenxing Street and north side of, Kaifang Road, Weixian High-tech Industrial Development Zone,
- City
- Xingtai Hebei
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K191970
Owner / Operator
- Firm Name
- Hebei Lufen Tech Co., Limited
- Operator Number
- 10090548
- Address
- Workshop No. 1, west side of Zhenxing Street and north side of, Kaifang Road, Weixian High-tech Industrial Development Zone,
- City
- Xingtai
- State
- Hebei
- Postal Code
- 065200
- Country
- CN
- Correspondent
- Hongxin Liu
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | KNS | Class 2 | Gastroenterology, Urology | No | 2025-12-16 |
| Device, Pressure Applying | KNM | Class 1 | Physical Medicine | No | 2025-12-16 |
| Gas, Laser Generating | NXF | Class 1 | General, Plastic Surgery | No | 2025-12-16 |
| Stimulator, Muscle, Powered | IPF | Class 2 | Physical Medicine | No | 2025-12-16 |
| Marker, Skin | FZZ | Class 1 | General, Plastic Surgery | No | 2025-12-16 |
| Powered Laser Surgical Instrument | GEX | Class 2 | General, Plastic Surgery | No | 2025-12-16 |
| High Intensity Focused Ultrasound System For Peripheral Neural Tissue Ablation | SGN | Class 2 | Neurology | No | 2025-12-16 |
| Powered Microneedle Device | QAI | Class 2 | General, Plastic Surgery | No | 2025-12-16 |
| Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers | PZL | Class 2 | General, Plastic Surgery | No | 2025-12-16 |
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | LXG | Class 1 | Clinical Chemistry | No | 2025-12-16 |
| Massager, Therapeutic, Electric | ISA | Class 1 | Physical Medicine | No | 2025-12-16 |
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
Tattoo Removal Machine
EMSfacial machine
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Export Device to the United States But Perform No Other Operation on Device