Seoul, KR · 11 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | Class II | General, Plastic Surgery | 8 | 2025-03-19 |
| NGX | Stimulator, Muscle, Powered, For Muscle Conditioning | Class II | Physical Medicine | 1 | 2026-04-10 |
| NFO | Stimulator, Transcutaneous Electrical, Aesthetic Purposes | Class II | Neurology | 1 | 2025-09-18 |
| PDZ | Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis | Class II | General, Plastic Surgery | 1 | 2022-07-20 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-04-10 | K253926 | Diacore | NGX | Class II | Physical Medicine |
| 2025-09-18 | K251649 | Sunny Plus (Sunny) | NFO | Class II | Neurology |
| 2025-03-19 | K242241 | Sunny | GEI | Class II | General, Plastic Surgery |
| 2024-09-25 | K241535 | Vybe RF II | GEI | Class II | General, Plastic Surgery |
| 2023-10-24 | K232223 | PlaDuo System | GEI | Class II | General, Plastic Surgery |
| 2023-07-06 | K230968 | VYBE RF Electrosurgical System | GEI | Class II | General, Plastic Surgery |
| 2022-07-20 | K221363 | AF Laser | PDZ | Class II | General, Plastic Surgery |
| 2021-11-23 | K211562 | Virtue RF | GEI | Class II | General, Plastic Surgery |
| 2021-04-26 | K193070 | VIVACE Electrosurgical Device | GEI | Class II | General, Plastic Surgery |
| 2021-01-22 | K202415 | VirtueRF | GEI | Class II | General, Plastic Surgery |
| 2020-12-14 | K201735 | PlaDuo System | GEI | Class II | General, Plastic Surgery |