Bejing, CN · 6 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | Class II | General, Plastic Surgery | 5 | 2026-06-04 |
| NGX | Stimulator, Muscle, Powered, For Muscle Conditioning | Class II | Physical Medicine | 1 | 2023-09-06 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-06-04 | K260690 | LumiGlam Laser System (SHE-LSP601-3) | GEX | Class II | General, Plastic Surgery |
| 2025-06-12 | K250936 | Q-Switched Nd:YAG Laser (SHE-LSP101-1) | GEX | Class II | General, Plastic Surgery |
| 2025-01-27 | K242941 | CO2 Laser Therapy Systems (SHE-LSP003-1) | GEX | Class II | General, Plastic Surgery |
| 2024-02-06 | K233416 | Cryojet Plus (SHE-ACP001-1) | GEX | Class II | General, Plastic Surgery |
| 2023-09-06 | K230024 | HI-EMT MAGSHAPE | NGX | Class II | Physical Medicine |
| 2020-04-06 | K191970 | Diode Laser Hair Removal System | GEX | Class II | General, Plastic Surgery |