Data / Medical devices / South Korea / Ltbio Co., Ltd.
Ltbio Co., Ltd.: FDA-registered device maker in Seongnam-si Gyeonggi, South Korea, 1 510(k) clearance
Ltbio Co., Ltd. is registered with the FDA (registration 3021743553) in Seongnam-si Gyeonggi, South Korea. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated August 29, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3021743553
- Address
- 1501, tech-dong, 124, Sagimakgol-ro, Jungwon-gu, Seongnam-si Gyeonggi, South Korea, 13207
- Owner or operator
- LTBIO Co., Ltd. (10084318)
- Roles
- Manufacturer
- First device listed
- September 14, 2022
- Registered through
- 2026
- Brand names listed
- OLIZ (model: LTB-1000A)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Lamp, Infrared, Therapeutic Heating | ILY | 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 |
|---|---|---|---|---|---|---|
| August 29, 2022 | K221189 | OLIZ LTB-1000A | ILY | Substantially Equivalent | Ltbio Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated August 29, 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.