Data / Medical devices / South Korea / Laon Medi Inc.
Laon Medi Inc.: FDA-registered device maker in Gwacheon-si, Gyeonggi-do, South Korea, 1 510(k) clearance
Laon Medi Inc. is registered with the FDA (registration 3042204491) in Gwacheon-si, Gyeonggi-do, South Korea. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated April 23, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3042204491
- Address
- C-504, 60 Gwacheon-daero 7na-gil, Gwacheon-si, Gyeonggi-do, South Korea, 13840
- Owner or operator
- LAON MEDI Inc. (10094409)
- Roles
- Manufacturer
- First device listed
- November 27, 2025
- Registered through
- 2026
- Brand names listed
- Laon Ortho
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Orthodontic Software | PNN | 2 | Manufacturer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | 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 23, 2025 | K250198 | Laon Ortho | PNN | Substantially Equivalent | Laon Medi, Inc. | accessdata.fda.gov |
Compare with other makers
Updated April 23, 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.