Deogyang-Gu, Goyang-Si, KR · 5 510(k) clearances · 2 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | Class II | General, Plastic Surgery | 2 | 2022-02-04 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | Class II | General, Plastic Surgery | 1 | 2025-08-11 |
| ONG | Powered Laser Surgical Instrument With MicrobeamFractional Output | Class II | General, Plastic Surgery | 1 | 2025-07-31 |
| NGX | Stimulator, Muscle, Powered, For Muscle Conditioning | Class II | Physical Medicine | 1 | 2022-10-14 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2026-01-27 | Class II | Ongoing | Z-1558-2026 | CLARITY II Laser System; Model No. 1110200210. | — | Reports of devices sparking/popping and potentially burning patients. |
| 2025-09-04 | Class II | Ongoing | Z-0146-2026 | XERF EFFECTOR 60. Electrosurgical unit. | — | Manufacturing defects in devices manufactured from 4/1/25 to 8/20/25 can on rare occasions result in adverse events for patients. |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2025-08-11 | K251327 | XERF | GEI | Class II | General, Plastic Surgery |
| 2025-07-31 | K244060 | eCO2 3D | ONG | Class II | General, Plastic Surgery |
| 2022-10-14 | K213748 | CoreLevee | NGX | Class II | Physical Medicine |
| 2022-02-04 | K213569 | HOLLYWOOD SPECTRA Laser System | GEX | Class II | General, Plastic Surgery |
| 2021-03-26 | K203788 | DermaV Laser System | GEX | Class II | General, Plastic Surgery |