Cleared Traditional

K260945 - Ultima System (UL-800)

Also marketed or referenced as:
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)
K260945 · Fit-Pro KFT (Ltd.) - DBA E-Fit · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2026
Decision
188d
Days
-
Risk

K260945 is an FDA 510(k) clearance for the Ultima System (UL-800).

Submitted by Fit-Pro KFT (Ltd.) - DBA E-Fit (Budapest, HU). The FDA issued a Cleared decision on September 27, 2026 after a review of 188 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Fit-Pro KFT (Ltd.) - DBA E-Fit devices

FDA 510(k) Submission Details - K260945

510(k) Number K260945 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 2026
Decision Date September 27, 2026
Days to Decision 188 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
72d slower than avg
Panel avg: 116d · This submission: 188d
Pathway characteristics
Predicate-based equivalence.

Device Classification - Class ,

Product Code -
Device Class -

Regulatory Consultant

Medical Device Academy, Inc.
Tom Cronin

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.