Yongin-Si, KR · 7 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | Class II | General, Plastic Surgery | 5 | 2026-04-06 |
| GEX | Powered Laser Surgical Instrument | Class II | General, Plastic Surgery | 1 | 2021-10-19 |
| PKT | Laser For Disruption Of Adipocyte Cells For Aesthetic Use | Class II | General, Plastic Surgery | 1 | 2020-12-01 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-04-06 | K260397 | SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002) | GEI | Class II | General, Plastic Surgery |
| 2025-09-29 | K251334 | NEW DOUBLO 2.0 | GEI | Class II | General, Plastic Surgery |
| 2024-11-08 | K241099 | Plasonic (Plasonic) | GEI | Class II | General, Plastic Surgery |
| 2024-06-24 | K233123 | SILKRO | GEI | Class II | General, Plastic Surgery |
| 2022-06-03 | K210084 | SILKRO | GEI | Class II | General, Plastic Surgery |
| 2021-10-19 | K201773 | PICOHI | GEX | Class II | General, Plastic Surgery |
| 2020-12-01 | K192970 | SLIMUS | PKT | Class II | General, Plastic Surgery |