510(k) K231394 ยท ONF Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
Intense Pulsed Light System
| Applicant | Smedtrum Medical Technology Co., Ltd., New Taipei City, TW |
| Decision | Substantially Equivalent, Aug 9, 2023 |
| Received | May 15, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K231394
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.