Data / Medical devices / South Korea / Ltra Global Co. Ltd.
Ltra Global Co. Ltd.: FDA-registered device maker in Seongnam Gyeonggi, South Korea, 1 510(k) clearance
Ltra Global Co. Ltd. is registered with the FDA (registration 3018116888) in Seongnam Gyeonggi, South Korea. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated January 22, 2021. Registered through 2026. 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
- 3018116888
- Address
- F502-F507 33 Sagimakgol-Ro, 62beon-Gil; Jungwon District, Seongnam Gyeonggi, South Korea, 13211
- Owner or operator
- LTRA Global Co. Ltd. (10080745)
- Roles
- Manufacturer
- First device listed
- February 23, 2021
- Registered through
- 2026
- Brand names listed
- Brightone, Miin
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Powered Laser Surgical Instrument | GEX | 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 |
|---|---|---|---|---|---|---|
| January 22, 2021 | K193266 | MIIN | GEX | Substantially Equivalent | Medico USA, Inc. | accessdata.fda.gov |
Compare with other makers
Updated January 22, 2021. 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.