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FDA 510(k)

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)

Numéro K : K260945 · 2026-09-27

DemandeurFit-Pro KFT (Ltd.) - DBA E-Fit
Date de décision2026-09-27
Code produit
DécisionSubstantially Equivalent

Résumé du dispositif

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) is the device name listed in this FDA 510(k) record. The listed applicant is Fit-Pro KFT (Ltd.) - DBA E-Fit. It received FDA 510(k) clearance on 2026-09-27 under 510(k) number K260945. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the 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)?

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) is a medical device that received FDA 510(k) clearance on 2026-09-27. The listed applicant is Fit-Pro KFT (Ltd.) - DBA E-Fit. The 510(k) number is K260945.

When did 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) receive FDA 510(k) clearance?

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) received FDA 510(k) clearance on 2026-09-27, under 510(k) number K260945.

Who is the listed applicant for 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)?

The FDA 510(k) record lists Fit-Pro KFT (Ltd.) - DBA E-Fit as the applicant. This does not by itself establish the device manufacturer.

Essais cliniques associés

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Source officielle

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