Data / Medical devices / Electrosurgical, Cutting & Coagulation & Accessories / South Korea
FDA-registered makers of Electrosurgical, Cutting & Coagulation & Accessories in South Korea: 29 establishments
29 establishments in South Korea are registered with the FDA to make Electrosurgical, Cutting & Coagulation & Accessories (product code GEI). 26 have a 510(k) clearance or PMA approval on file and 1 has a recall event. 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.
- Device
- Electrosurgical, Cutting & Coagulation & Accessories
- Product code
- GEI
- Country
- South Korea
Makers of Electrosurgical, Cutting & Coagulation & Accessories in South Korea
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Jeisys Medical Inc. | Seoul, South Korea | Manufacturer | 9 | September 11, 2026 | 0 | 0 | 0 | api.fda.gov |
| Starmed Co.,ltd | Ilsandong-gu, Goyang-si Gyeonggi, South Korea | Manufacturer | 9 | May 26, 2026 | 0 | 0 | 0 | api.fda.gov |
| Agnes Medical Co.,ltd | Seongnam-si Gyeonggi, South Korea | Manufacturer | 7 | September 3, 2025 | 0 | 0 | 0 | api.fda.gov |
| LivsMed Inc. | Seongnam-si Gyeonggi, South Korea | Manufacturer | 6 | October 21, 2025 | 0 | 0 | 0 | api.fda.gov |
| ShenB Co Ltd | Seongdong-gu Seoul, South Korea | Manufacturer | 6 | March 19, 2025 | 0 | 0 | 0 | api.fda.gov |
| Classys Inc | Anyang-si Gyeonggi, South Korea | Manufacturer | 5 | November 21, 2024 | 0 | 0 | 0 | api.fda.gov |
| Hironic Co., Ltd. | Yongin-Si Gyeonggi, South Korea | Manufacturer | 5 | April 6, 2026 | 0 | 0 | 0 | api.fda.gov |
| VIOL Medical CO., LTD. | Seongnam-si Gyeonggi, South Korea | Manufacturer | 5 | August 27, 2026 | 0 | 0 | 0 | api.fda.gov |
| Bio Protech, Inc. | Wonju-si Gangwon, South Korea | Manufacturer | 4 | July 16, 2015 | 0 | 0 | 0 | api.fda.gov |
| Hironic Co., Ltd. | Cheongju-si Chungbuk, South Korea | Manufacturer | 4 | September 29, 2025 | 0 | 0 | 0 | api.fda.gov |
| RF Medical Co., Ltd | Seoul, South Korea | Complaint file establishment, Manufacturer | 4 | October 4, 2023 | 0 | 0 | 0 | api.fda.gov |
| Cynosure Lutronic Technology Corporation | Goyang Gyeonggi, South Korea | Manufacturer | 3 | June 29, 2026 | 0 | 0 | 0 | api.fda.gov |
| WONTECH Co., Ltd. | Daejeon, South Korea | Manufacturer | 3 | January 21, 2025 | 0 | 0 | 0 | api.fda.gov |
| Chungwoo Co., Ltd. | Geumcheon-gu Seoul, South Korea | Manufacturer | 2 | May 23, 2024 | 0 | 0 | 0 | api.fda.gov |
| CNC Technologies | GWANGMYEONG-SI Gyeonggi, South Korea | Manufacturer | 2 | August 11, 2025 | 0 | 0 | 0 | api.fda.gov |
| Lutronic Corporation | Daegu Gyeongbuk, South Korea | Manufacturer | 2 | December 10, 2018 | 0 | 0 | 0 | api.fda.gov |
| Asterasys Co., Ltd. | Seongdong-gu Seoul, South Korea | Manufacturer | 1 | October 16, 2025 | 0 | 0 | 0 | api.fda.gov |
| Bomtech Electronics Co., Ltd. | Seoul, South Korea | Manufacturer | 1 | December 26, 2024 | 0 | 0 | 0 | api.fda.gov |
| Britzmedi Co., Ltd. | Seongnam-si Gyeonggi, South Korea | Manufacturer | 1 | September 27, 2022 | 0 | 0 | 0 | api.fda.gov |
| Classys Inc | Republic of Korea Seoul, South Korea | Manufacturer | 1 | April 29, 2024 | 0 | 0 | 0 | api.fda.gov |
| CnS MEDICAL CO., LTD. | Pocheon-si Gyeonggi, South Korea | Manufacturer | 1 | June 6, 2025 | 0 | 0 | 0 | api.fda.gov |
| Cynosure Lutronic Technology Corporation | Daegu Gyeongbuk, South Korea | Manufacturer | 1 | December 10, 2018 | 0 | 0 | 0 | api.fda.gov |
| Imedicom Co., Ltd. | Gunpo-si Gyeonggi, South Korea | Manufacturer | 1 | March 18, 2016 | 0 | 0 | 0 | api.fda.gov |
| Lutronic Corporation | Goyang-si Gyeonggi, South Korea | Manufacturer | 1 | June 25, 2013 | 0 | 1 | 0 | api.fda.gov |
| Skingrab | GEUMCHEON-GU Seoul, South Korea | Manufacturer | 1 | December 20, 2024 | 0 | 0 | 0 | api.fda.gov |
| Tentech Inc. | Seoul, South Korea | Manufacturer | 1 | December 20, 2023 | 0 | 0 | 0 | api.fda.gov |
| Blue T Korea Co., Ltd. | Siheung-si Gyeonggi, South Korea | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Do-All Corp. | Seoul, South Korea | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Em Tech.inc | Bucheon-si Gyeonggi, South Korea | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 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.