510(k) K221214 ยท ONF Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
Hand-held IPL device (IPL Home Use Hair Removal Device) Model:FZ-608, FZ-608G, FZ-100, FZ-200
| Applicant | Shenzhen Ionka Medical Technology Co., Ltd., Shenzhen, CN |
| Decision | Substantially Equivalent, Sep 21, 2022 |
| Received | Apr 27, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K221214
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.