# K260945: 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)

- Pathway: 510(k) (Traditional)
- Applicant: Fit-Pro KFT (Ltd.) - DBA E-Fit
- Decided: Sep 27, 2026 after 188 days
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 27 generations back to K943450 (1995). 329 ancestors in all.
No later device cites it as a predicate yet.
0 of 330 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202148: E-Fit Infinity System (EF-2090 Controller and EF-100 Unit), Fit-Pro, Ltd. (2021) Summary page 5.
- K242532: BTL-785BNF-E, BTL Industries, Inc. (2024) Summary page 5.
- K212275: Dermalux Flex MD, Aesthetic Technology, Ltd. (2021) Summary page 5.

## Cited in the summary but kept off the family tree
- K15133: LightStim for Pain LED Belt. Number could not be read Summary page 5.

## Indications for use
The ULTIMA UL-800 System is intended for use in adults 22 years of age and older. The system is designated for for prescription use only in professional healthcare settings. The ULTIMA UL-800 System provides two energy modalities, electrical stimulation and light output. Electrical stimulation has separate body NGX and facial NFO applications. Electrical stimulation and light output are operated separately and cannot be delivered simultaneously. NGX electrical muscle stimulation function The ULTIMA UL-800 System is intended to apply electrical current through surface electrodes to healthy muscles for muscle-conditioning purposes by temporarily affecting the stimulated muscle’s contractile properties, force output, and/or fatigue resistance. The NGX function is not intended for rehabilitation or for the treatment of patients with medical conditions. NGX is available with UL-PAD-IR1 / IR2 / IR3 / IR4 for the labeled body parts. NFO facial aesthetic electrical stimulation function When UL-FACE is operated in the separate NFO electrical stimulation mode, the ULTIMA UL-800 System is indicated for aesthetic use including facial skin stimulation. Application is limited to the labeled forehead and cheek sites on intact skin. This function is not intended for rehabilitation, treatment of medical conditions, or conditioning of facial muscles to improve contractile properties, force output, or fatigue resistance. ILY topical-heating light function When UL-FACE is operated in the separate ILY light mode, the ULTIMA UL-800 System is intended to emit energy in the visible red and near-infrared spectrum to provide topical heating for the purpose of elevating tissue temperature, temporarily increasing local blood circulation, and temporarily relaxing muscles.

Source page: https://510kreport.com/device/K260945
Methodology: https://510kreport.com/methodology