510(k) K192521 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, Dec 6, 2019 |
| Received | Sep 13, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192521
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.