Data / Medical devices / South Korea / Agnes Medical Co.,ltd
Agnes Medical Co.,ltd: FDA-registered device maker in Seongnam-si Gyeonggi, South Korea, 7 510(k) clearances
Agnes Medical Co.,ltd is registered with the FDA (registration 3010164891) in Seongnam-si Gyeonggi, South Korea. It lists 3 device types. The FDA files 7 510(k) clearances under its listings, the newest dated September 3, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010164891
- Address
- #, 24 Dunchon-daero 388beon-gil,Jungwon-gu, Seongnam-si Gyeonggi, South Korea, 13403
- Owner or operator
- AGNES MEDICAL CO., LTD. (10049778)
- Roles
- Manufacturer
- First device listed
- July 28, 2015
- Registered through
- 2026
- Brand names listed
- AG-CN-23G, AG-CN18G, AG-CN18G, AG-CN19G, AG-CN20G, AG-CN21G, AG-CN-23G, AG-CN19G, AG-CN20G, AG-CN21G, AGNES, AGNES Ultra and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Manufacturer | accessdata.fda.gov |
| Epilator, High Frequency, Needle-Type | KCW | 1 | Manufacturer | accessdata.fda.gov |
| Vibrator, Therapeutic | IRO | 1 | 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 |
|---|---|---|---|---|---|---|
| September 3, 2025 | K250217 | AGNES Ultra | GEI | Substantially Equivalent | Agnes Medical Co., Ltd. | accessdata.fda.gov |
| February 29, 2024 | K230837 | PlazMagik | GEI | Substantially Equivalent | Agnes Medical Co., Ltd. | accessdata.fda.gov |
| May 4, 2023 | K223805 | Agnes | GEI | Substantially Equivalent | Agnes Medical Co., Ltd. | accessdata.fda.gov |
| July 14, 2022 | K203013 | AGNES | GEI | Substantially Equivalent | Agnes Medical Co., Ltd. | accessdata.fda.gov |
| October 24, 2019 | K192728 | Agnes | GEI | Substantially Equivalent | Agnes Medical Co., Ltd. | accessdata.fda.gov |
| August 8, 2017 | K171707 | GA-B, GA-C, GA-E, GA-I, GA-S, GA-W3A, GA-F3A, GA-IL, GA-SL, GA-W3B, GA-F1A | GEI | Substantially Equivalent | Gowoonsesang Cosmetics Co., Ltd. | accessdata.fda.gov |
| January 5, 2017 | K160469 | AGNES | GEI | Substantially Equivalent | Gowoonsesang Cosmetics Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Electrosurgical, Cutting & Coagulation & Accessories
- All makers of Epilator, High Frequency, Needle-Type
- All makers of Vibrator, Therapeutic
Updated September 3, 2025. 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.