Shenzhen, CN · 4 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | Class II | Cardiovascular | 1 | 2025-02-19 |
| OHT | Light Based Over-The-Counter Hair Removal | Class II | General, Plastic Surgery | 1 | 2023-04-06 |
| FLL | Continuous Measurement Thermometer | Class II | General Hospital | 1 | 2021-07-23 |
| DQA | — | — | — | 1 | 2020-12-14 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2025-02-19 | K241578 | Wrist Digital Blood Pressure Monitor (BSX312, BSX313, BSX315, BSX322, BSX323, BSX353, BSX355) | DXN | Class II | Cardiovascular |
| 2023-04-06 | K230097 | IPL Hair Removal Device, Model(s): BSXT101, BSXT102, BSXT103, BSXT105, BSXT106, BSXT108 | OHT | Class II | General, Plastic Surgery |
| 2021-07-23 | K202296 | Infrared Forehead Thermometer, Model BSX976 | FLL | Class II | General Hospital |
| 2020-12-14 | K202324 | Fingertip Pulse Oximeter | DQA | — | — |