Data / Medical devices / South Korea / 3D Ons, Inc.
3D Ons, Inc.: FDA-registered device maker in Gangnam-gu Seoul, South Korea, 1 510(k) clearance
3D Ons, Inc. is registered with the FDA (registration 3023266032) in Gangnam-gu Seoul, South Korea. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated May 23, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3023266032
- Address
- 18, Eonju-ro 171-gil, Gangnam-gu Seoul, South Korea, 06023
- Owner or operator
- 3D ONS, Inc. (10085447)
- Roles
- Manufacturer
- First device listed
- June 19, 2022
- Registered through
- 2026
- Brand names listed
- ON3D
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| May 23, 2022 | K221000 | ON3D | LLZ | Substantially Equivalent | 3D Ons, Inc. | accessdata.fda.gov |
Compare with other makers
Updated May 23, 2022. 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.