Data / Medical devices / China / Shenzhen Lifotronic Technology Co.,Ltd.
Shenzhen Lifotronic Technology Co.,Ltd.: FDA-registered device maker in Shenzhen Guangdong, China, 2 510(k) clearances
Shenzhen Lifotronic Technology Co.,Ltd. is registered with the FDA (registration 3012289707) in Shenzhen Guangdong, China. It lists 5 device types. The FDA files 2 510(k) clearances under its listings, the newest dated July 30, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012289707
- Address
- Lifotronic Tower, No. 8, Qiuzhi East Road, Guancheng Community, Guanhu Street Longhua, Shenzhen Guangdong, China, 518110
- Owner or operator
- Shenzhen Lifotronic Technology Co., Ltd. (10055994)
- Roles
- Manufacturer
- First device listed
- December 19, 2019
- Registered through
- 2026
- Brand names listed
- Air Compression Therapy System, Airway Clearance System, Canister(CL1000; CL500; CS300; CS500), Diode Laser Hair Removal Machine(models:T60A, T60B, T60C, T60D, T60E), SARS- CoV-2 lgG Assay Kits (Lateral Flow Immunoassay), SARS- CoV-2 lgM Assay Kits (Lateral Flow Immunoassay), SARS-CoV-2 IgG (Electrochemiluminescence Immunoassay), SARS-CoV-2 IgM (Electrochemiluminescence Immunoassay) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bottle, Collection, Vacuum | KDQ | 2 | Manufacturer | accessdata.fda.gov |
| Massager, Powered Inflatable Tube | IRP | 2 | Manufacturer | accessdata.fda.gov |
| Massager, Therapeutic, Electric | ISA | 1 | Manufacturer | accessdata.fda.gov |
| Powered Laser Surgical Instrument | GEX | 2 | Manufacturer | accessdata.fda.gov |
| Reagent, Coronavirus Serological | QKO | N | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 30, 2025 | K251076 | Diode Laser Hair Removal Machine (models: T60A, T60B, T60C, T60D, T60E) | GEX | Substantially Equivalent | Shenzhen Lifotronic Technology Co., Ltd. | accessdata.fda.gov |
| June 22, 2020 | K192466 | Air Compression Therapy System | IRP | Substantially Equivalent | Shenzhen Lifotronic Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Massager, Therapeutic, Electric
- All makers of Reagent, Coronavirus Serological
- All makers of Bottle, Collection, Vacuum
- All makers of Massager, Powered Inflatable Tube
- All makers of Powered Laser Surgical Instrument
Updated July 30, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.