Ultima System (UL-800);Ultimate Face Package (UL-800-Face-Set);Ultimate Shape Extension Kit 1 (UL-800-Shape-Ext-Kit-1);Ultimate Shape Extension Kit 2 (UL-800-Shape-Ext-Kit-2)
| Applicant | Fit-Pro KFT (Ltd.) - DBA E-Fit, Budapest, HU |
| Decision | Substantially Equivalent, Sep 27, 2026 |
| Received | Mar 23, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260945
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.