510(k) K221011 ยท QAI Powered Microneedle Device
AI.ME System
| Applicant | Venus Concept USA, Inc., Weston FL, US |
| Decision | Substantially Equivalent, Dec 20, 2022 |
| Received | Apr 5, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K221011
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.