Data / Medical devices / Powered Laser Surgical Instrument With MicrobeamFractional Output / South Korea
FDA-registered makers of Powered Laser Surgical Instrument With MicrobeamFractional Output in South Korea: 10 establishments
10 establishments in South Korea are registered with the FDA to make Powered Laser Surgical Instrument With MicrobeamFractional Output (product code ONG). 5 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 3, 2026.
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- Device
- Powered Laser Surgical Instrument With MicrobeamFractional Output
- Product code
- ONG
- Country
- South Korea
Makers of Powered Laser Surgical Instrument With MicrobeamFractional Output in South Korea
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Cynosure Lutronic Technology Corporation | Goyang Gyeonggi, South Korea | Manufacturer | 2 | July 31, 2025 | 0 | 0 | 0 | api.fda.gov |
| Ids Ltd | Paju Gyeonggi, South Korea | Manufacturer | 1 | February 2, 2018 | 0 | 1 | 0 | api.fda.gov |
| Jeisys Medical Inc. | Seoul, South Korea | Manufacturer | 1 | November 10, 2010 | 0 | 0 | 0 | api.fda.gov |
| Lutronic Corporation | Goyang-si Gyeonggi, South Korea | Manufacturer | 1 | January 20, 2011 | 0 | 0 | 0 | api.fda.gov |
| SRMC Co., Ltd. | Cheongju-si Chungbuk, South Korea | Manufacturer | 1 | December 24, 2014 | 0 | 0 | 0 | api.fda.gov |
| Amt Engineering Co., Ltd. | Seongnam-si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bison Medical Co., Ltd | Geumcheon gu Seoul, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| BLUECORE COMPANY Co., Ltd. | Yangsan Gyeongnam, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Classys Inc | Anyang-si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SNJ Co Ltd | Guro-Gu Seoul, South Korea | 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.