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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K260945
Device Name 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
Szabadság Ter. 7
Budapest,  HU 1054
Applicant Contact Janos Papp
Correspondent
Medical Device Academy, Inc.
345 Lincoln Hill Rd.
Shrewsbury,  VT  05738
Correspondent Contact Tom Cronin
Date Received03/23/2026
Decision Date 09/27/2026
Decision Substantially Equivalent (SESE)
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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