510(k) K261204 · ONF Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
Intense Pulsed Light Therapy Device
| Applicant | Sanhe LEFIS Electronics Co., Ltd., Langfang, CN |
| Decision | Substantially Equivalent, Jun 12, 2026 |
| Received | Apr 13, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K261204
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.