FDA Registration
Active
🇨🇳 China
Shenzhen Lifotronic Technology Co.,Ltd.
Reg #: 3012289707
·
FEI: 3012289707
·
Expires 2026
Products
6
Proprietary Names
10
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- Shenzhen Lifotronic Technology Co.,Ltd.
- Registration Number
- 3012289707
- FEI Number
- 3012289707
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Lifotronic Tower, No. 8, Qiuzhi East Road, Guancheng Community, Guanhu Street, Longhua
- City
- Shenzhen Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K251076
Owner / Operator
- Firm Name
- Shenzhen Lifotronic Technology Co., Ltd.
- Operator Number
- 10055994
- Address
- Lifotronic Tower, No. 8, Qiuzhi East Road, Guancheng Community, Guanhu Street, Longhua
- City
- Shenzhen
- State
- Guangdong
- Postal Code
- 518110
- Country
- CN
- Correspondent
- Lei Xiang
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Powered Laser Surgical Instrument | GEX | Class 2 | General, Plastic Surgery | No | 2025-07-31 |
| Bottle, Collection, Vacuum | KDQ | Class 2 | General Hospital | No | 2020-09-07 |
| Massager, Therapeutic, Electric | ISA | Class 1 | Physical Medicine | No | 2019-12-19 |
| Massager, Powered Inflatable Tube | IRP | Class 2 | Physical Medicine | No | 2020-07-07 |
| Reagent, Coronavirus Serological | QKO | Class N | Unknown | No | 2020-04-16 |
| Fluorometer | JZT | Class 1 | Immunology | No | 2017-10-30 |
Proprietary Names
Diode Laser Hair Removal Machine(models:T60A, T60B, T60C, T60D, T60E)
Canister(CL1000; CL500; CS300; CS500)
Shock Wave Therapy System(LC-310; LC-320; LC-560; LC-570; LC-580;UW210)
Airway Clearance System
Air Compression Therapy System
SARS- CoV-2 lgM Assay Kits (Lateral Flow Immunoassay)
SARS- CoV-2 lgG Assay Kits (Lateral Flow Immunoassay)
SARS-CoV-2 IgG (Electrochemiluminescence Immunoassay)
SARS-CoV-2 IgM (Electrochemiluminescence Immunoassay)
FA-100; FA-160
Establishment Types
Manufacture Medical Device