Ultima System (UL-800) +3 more— 510(k) K260945
Substantially EquivalentFit-Pro KFT (Ltd.) - DBA E-Fit
FDA 510(k) clearance K260945 for Ultima System (UL-800) +3 more, Substantially Equivalent on 2026-09-27. Applicant: Fit-Pro KFT (Ltd.) - DBA E-Fit.
Summary
This clearance covers the Ultima System (UL-800) plus three add-ons: the Ultimate Face Package, Ultimate Shape Extension Kit 1, and Ultimate Shape Extension Kit 2. The record has no product code, device class, or regulation number, and the advisory panel field reads Unknown. With nothing beyond the product names, the record doesn't establish what the system does.
Fit-Pro KFT (Ltd.), doing business as E-Fit, filed it as a Traditional 510(k) from Budapest, Hungary.
Review took 188 days (March 23 to September 27, 2026).
Clearance details
- Device name as filed
- 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
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Budapest, HU
Data sourced from openFDA. This site is unofficial and independent of the FDA.