510(k) K212907 ยท ONF Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
Aimanfun Lumea Comfort, A-2789/A-3588
| Applicant | Kam Yuen Plastic Products , Ltd., Zhongshan, CN |
| Decision | Substantially Equivalent, Dec 2, 2021 |
| Received | Sep 13, 2021 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K212907
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.