Data / Medical devices / South Korea / Oculight Co.,Ltd.
Oculight Co.,Ltd.: FDA-registered device maker in Seongnam, South Korea, 1 510(k) clearance
Oculight Co.,Ltd. is registered with the FDA (registration 3019810045) in Seongnam, South Korea. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated August 20, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3019810045
- Address
- 46 Dallaenae-Ro Sujeong District, Seongnam, South Korea, 13449
- Owner or operator
- Oculight Co. Ltd. (10082160)
- Roles
- Manufacturer
- First device listed
- June 21, 2021
- Registered through
- 2026
- Brand names listed
- iChopper, iVision
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Endoilluminator | MPA | 2 | Manufacturer | accessdata.fda.gov |
| Led Light Source | NTN | 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 20, 2021 | K202670 | Nam illumination probe with chopper | MPA | Substantially Equivalent | Oculight , Ltd. | accessdata.fda.gov |
Compare with other makers
Updated August 20, 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.