Data / Medical devices / Powered Light Based Non-Laser Surgical Instrument With Thermal Effect / South Korea
FDA-registered makers of Powered Light Based Non-Laser Surgical Instrument With Thermal Effect in South Korea: 6 establishments
6 establishments in South Korea are registered with the FDA to make Powered Light Based Non-Laser Surgical Instrument With Thermal Effect (product code ONF). 5 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 3, 2026.
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- Device
- Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
- Product code
- ONF
- Country
- South Korea
Makers of Powered Light Based Non-Laser Surgical Instrument With Thermal Effect in South Korea
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Amt Engineering Co., Ltd. | Seongnam-si Gyeonggi, South Korea | Manufacturer | 1 | May 30, 2014 | 0 | 0 | 0 | api.fda.gov |
| Ids Ltd | Paju Gyeonggi, South Korea | Manufacturer | 1 | October 5, 2018 | 0 | 0 | 0 | api.fda.gov |
| Ids Ltd | Geumcheon-gu Seoul, South Korea | Manufacturer | 1 | October 5, 2018 | 0 | 0 | 0 | api.fda.gov |
| Jeisys Medical Inc. | Seoul, South Korea | Manufacturer | 1 | March 5, 2010 | 0 | 0 | 0 | api.fda.gov |
| Tentech Inc. | Seoul, South Korea | Complaint file establishment, Exporter to the US, Manufacturer | 1 | November 10, 2022 | 0 | 0 | 0 | api.fda.gov |
| Nson Co., Ltd. | Anyang Gyeonggi, South Korea | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 3, 2026. 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.