510(k) K230816 ยท ONF Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
Intense Pulsed Light Treatment System
| Applicant | Shangdong Huamei Technology Co., Ltd., Weifang, CN |
| Decision | Substantially Equivalent, Apr 21, 2023 |
| Received | Mar 24, 2023 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K230816
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.