Data / Medical devices / South Korea / SNJ Co Ltd
SNJ Co Ltd: FDA-registered device maker in Guro-Gu Seoul, South Korea, 2 510(k) clearances
SNJ Co Ltd is registered with the FDA (registration 3004633032) in Guro-Gu Seoul, South Korea. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated April 12, 2022. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3004633032
- Address
- No. 602-1, 604, Ace-Techno Tower 2, 19 Digital-Ro 31-Gil, Guro-Gu Seoul, South Korea, 08381
- Owner or operator
- SNJ CO LTD (10061663)
- Roles
- Manufacturer
- First device listed
- March 15, 2022
- Registered through
- 2027
- Brand names listed
- Finebeam, Finexel
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Powered Laser Surgical Instrument | GEX | 2 | Manufacturer | accessdata.fda.gov |
| Powered Laser Surgical Instrument With MicrobeamFractional Output | ONG | 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 12, 2022 | K213557 | Finexel | GEX | Substantially Equivalent | SNJ Co., Ltd. | accessdata.fda.gov |
| November 19, 2021 | K202288 | Finebeam | GEX | Substantially Equivalent | SNJ Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Powered Laser Surgical Instrument
- All makers of Powered Laser Surgical Instrument With MicrobeamFractional Output
Updated April 12, 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.