Data / Medical devices / South Korea / GCS Co.,ltd
GCS Co.,ltd: FDA-registered device maker in Seongnam-si Gyeonggi, South Korea, 1 510(k) clearance
GCS Co.,ltd is registered with the FDA (registration 3013924508) in Seongnam-si Gyeonggi, South Korea. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated October 27, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013924508
- Address
- #301~327, 33, Sagimakgol-ro 62beon-gil, Jungwon-gu, Seongnam-si Gyeonggi, South Korea, 13211
- Owner or operator
- GCS Co.,LTD (10057779)
- Roles
- Manufacturer
- First device listed
- May 24, 2018
- Registered through
- 2026
- Brand names listed
- LEAF, PLAXPOT, Plasmatique, Plaxpot Multi Plasma, SYNA+, SYNAPLUS, SYNAPLUS PRO
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Low Power Electrosurgical Devices For Skin Lesion Destruction | QVJ | 2 | Manufacturer | accessdata.fda.gov |
| Massager, Therapeutic, Electric | ISA | 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 |
|---|---|---|---|---|---|---|
| October 27, 2023 | K220493 | Plaxpot Multi Plasma | QVJ | Substantially Equivalent | Gcs Co. Limited | accessdata.fda.gov |
Compare with other makers
- All makers of Massager, Therapeutic, Electric
- All makers of Low Power Electrosurgical Devices For Skin Lesion Destruction
Updated October 27, 2023. 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.