Data / Medical devices / China / Litu Tech Ltd.
Litu Tech Ltd.: FDA-registered device maker in Zhongshan Guangdong, China, 1 510(k) clearance
Litu Tech Ltd. is registered with the FDA (registration 3048247380) in Zhongshan Guangdong, China. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated April 30, 2024. Registered through 2027. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3048247380
- Address
- 3/F, Bldg. A, No. 97 North Dongzhen Road, Torch Zone, Zhongshan Guangdong, China, 528437
- Owner or operator
- Litu Tech Ltd. (10096053)
- Roles
- Manufacturer
- First device listed
- June 13, 2026
- Registered through
- 2027
- Brand names listed
- High Speed Air Turbine (Model:Max ST 4H Mini; Max 4H; Max T; Mini Max 45 4H; Mini Max 45; Mini Max QC; Max Torque QC ), High Speed Air Turbine (Model:Mini Max Torque; Mini OPT; Mini OPT Torque ), High Speed Air Turbine Handpiece (Model: G100,G200,G300,G400,G450,G500,G600,G700,G700L,G800,G800L)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Handpiece, Air-Powered, Dental | EFB | 1 | 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 |
|---|---|---|---|---|---|---|
| April 30, 2024 | K233122 | High Speed Air Turbine Handpiece (G100,G200,G300,G400,G450,G500,G600,G700,G700L,G800,G800L) | EFB | Substantially Equivalent | Litu Tech , Ltd. | accessdata.fda.gov |
Compare with other makers
Updated April 30, 2024. 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.