Beijing, CN · 6 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | Class II | General, Plastic Surgery | 3 | 2024-12-20 |
| ONF | Powered Light Based Non-Laser Surgical Instrument With Thermal Effect | Class II | General, Plastic Surgery | 1 | 2024-03-15 |
| NGX | Stimulator, Muscle, Powered, For Muscle Conditioning | Class II | Physical Medicine | 1 | 2023-07-07 |
| OLP | Over-The-Counter Powered Light Based Laser For Acne | Class II | General, Plastic Surgery | 1 | 2020-05-01 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2024-12-20 | K241670 | Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System (FG900-S2) | GEX | Class II | General, Plastic Surgery |
| 2024-03-15 | K233307 | Intensity Pulsed Light Therapy System | ONF | Class II | General, Plastic Surgery |
| 2024-02-20 | K231896 | Diode Laser Therapy System | GEX | Class II | General, Plastic Surgery |
| 2023-07-07 | K231318 | Electromagnetic Stimulator Device(Model EM Contouring and Tesla Duet) | NGX | Class II | Physical Medicine |
| 2022-08-23 | K220268 | Picosecond Laser System (Model PS10-A and PS10-B) | GEX | Class II | General, Plastic Surgery |
| 2020-05-01 | K192295 | PDT-FACE | OLP | Class II | General, Plastic Surgery |