510(k) · Cleared
ClearedUltima 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)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fit-Pro KFT (Ltd.) - DBA E-Fit
Cleared on Sep 27, 2026 as substantially equivalent to K202148 (Fit-Pro, Ltd., 2021) and 2 other predicates after a 188-day review. Its family tree reaches back 27 generations to 1995.
- Decided
- Sep 27, 2026
- Review
- 188 days
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 27 generations to K943450 (1995). 329 ancestors in all, the oldest K800617 (1980). No later device cites it as a predicate yet.
- Root · 27 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 23 generations between
- 3 generations backK222556 BTL-785XBTL Industries, Inc. · 2023
- 2 generations backK233604 BTL-785SBTL Industries, Inc. · 2024
- 1 generation backK242532 BTL-785BNF-EBTL Industries, Inc. · 2024
- This deviceK260945 Ultima System (UL-800);Ultimate Face Package…Fit-Pro KFT (Ltd.) - DBA E-Fit · 2026
Show all 27 generations
- Root · 27 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 26 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 25 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 24 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 23 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 22 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 21 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 20 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 19 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 18 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 17 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 16 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 15 generations backK051214 Aluma Skin Renewal SystemLumenis, Inc. · 2005
- 14 generations backK070004 AccentAlma Lasers, Ltd. · 2007
- 13 generations backK072699 Alma Lasers Family of Accent Radiofrequency (RF) Systems, Models…Alma Lasers, Ltd. · 2007
- 12 generations backK101967 Non-Ablative Wrinkle Treatent Handpiece Modle Pelleve'Ellman Int'L, Inc. · 2010
- 11 generations backK102368 Non-Ablative Wrinkle Treatment HandpieceEllman Int'L, Inc. · 2010
- 10 generations backK102698 Pelleve Glidesafe Non-Ablative Wrinkle Treatment System Model…Ellman Int'L, Inc. · 2011
- 9 generations backK132665 Pelleve Glidesafe 10MM, 15MM & 20MM Handpiece, Pelleve S5 - IecEllman International, Inc. · 2013
- 8 generations backK171262 TempSureCynosure, Inc. · 2017
- 7 generations backK182365 TempSure SystemCynosure, Inc. · 2018
- 6 generations backK190678 TempSureCynosure, Inc. · 2019
- 5 generations backK200241 TempSure SystemCynosure, LLC · 2020
- 4 generations backK211639 BTL-785WBTL Industries, Inc. · 2022
- 3 generations backK222556 BTL-785XBTL Industries, Inc. · 2023
- 2 generations backK233604 BTL-785SBTL Industries, Inc. · 2024
- 1 generation backK242532 BTL-785BNF-EBTL Industries, Inc. · 2024
- This deviceK260945 Ultima System (UL-800);Ultimate Face Package…Fit-Pro KFT (Ltd.) - DBA E-Fit · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −27 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −26 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −25 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −24 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −23 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −22 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −21 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −20 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −19 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −18 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −17 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −16 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −15 | K051214 | Aluma Skin Renewal System | Lumenis, Inc. | 2005 | — |
| −14 | K070004 | Accent | Alma Lasers, Ltd. | 2007 | — |
| −13 | K072699 | Alma Lasers Family of Accent Radiofrequency (RF) Systems, Models: Accent… | Alma Lasers, Ltd. | 2007 | — |
| −12 | K101967 | Non-Ablative Wrinkle Treatent Handpiece Modle Pelleve' | Ellman Int'L, Inc. | 2010 | — |
| −11 | K102368 | Non-Ablative Wrinkle Treatment Handpiece | Ellman Int'L, Inc. | 2010 | — |
| −10 | K102698 | Pelleve Glidesafe Non-Ablative Wrinkle Treatment System Model Pelleve Glidesafe | Ellman Int'L, Inc. | 2011 | — |
| −9 | K132665 | Pelleve Glidesafe 10MM, 15MM & 20MM Handpiece, Pelleve S5 - Iec | Ellman International, Inc. | 2013 | — |
| −8 | K171262 | TempSure | Cynosure, Inc. | 2017 | — |
| −7 | K182365 | TempSure System | Cynosure, Inc. | 2018 | — |
| −6 | K190678 | TempSure | Cynosure, Inc. | 2019 | — |
| −5 | K200241 | TempSure System | Cynosure, LLC | 2020 | — |
| −4 | K211639 | BTL-785W | BTL Industries, Inc. | 2022 | — |
| −3 | K222556 | BTL-785X | BTL Industries, Inc. | 2023 | — |
| −2 | K233604 | BTL-785S | BTL Industries, Inc. | 2024 | — |
| −1 | K242532 | BTL-785BNF-E | BTL Industries, Inc. | 2024 | — |
| 0 (this device) | K260945 | Ultima System (UL-800);Ultimate Face Package (UL-800-Face-Set);Ultimate Shape… | Fit-Pro KFT (Ltd.) - DBA E-Fit | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1982 | 2 | 0 |
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 5 | 0 |
| 1992 | 3 | 0 |
| 1993 | 8 | 0 |
| 1994 | 19 | 0 |
| 1995 | 18 | 0 |
| 1996 | 21 | 0 |
| 1997 | 22 | 0 |
| 1998 | 17 | 0 |
| 1999 | 11 | 0 |
| 2000 | 24 | 0 |
| 2001 | 24 | 0 |
| 2002 | 31 | 0 |
| 2003 | 25 | 0 |
| 2004 | 11 | 0 |
| 2005 | 11 | 0 |
| 2006 | 3 | 0 |
| 2007 | 5 | 0 |
| 2008 | 2 | 0 |
| 2009 | 6 | 0 |
| 2010 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 5 | 0 |
| 2014 | 4 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in this category? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K202148 | E-Fit Infinity System (EF-2090 Controller and EF-100 Unit)Summary page 5…Product Code(s) NGX, NFO, ILY | Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K202148 E-Fit Infinity System NGX K242532 BTL-785BNF-E NFO K212275 Dermalux Flex MD ILY K15133 LightStim for Pain LED Belt ILY | Device… | 2021 |
| * | K242532 | BTL-785BNF-ESummary page 5…egally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K202148 E-Fit Infinity System NGX K242532 BTL-785BNF-E NFO K212275 Dermalux Flex MD ILY K15133 LightStim for Pain LED Belt ILY | Device Description Summary 21 CFR 807.92(… | 2024 |
| * | K212275 | Dermalux Flex MDSummary page 5…Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K202148 E-Fit Infinity System NGX K242532 BTL-785BNF-E NFO K212275 Dermalux Flex MD ILY K15133 LightStim for Pain LED Belt ILY | Device Description Summary 21 CFR 807.92(a)(4) The… | 2021 |
| Kept off the family tree | K15133 | LightStim for Pain LED Belt Number could not be read Summary page 5…Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K202148 E-Fit Infinity System NGX K242532 BTL-785BNF-E NFO K212275 Dermalux Flex MD ILY K15133 LightStim for Pain LED Belt ILY | Device Description Summary 21 CFR 807.92(a)(4) The ULTIMA UL-800 System is an… |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 31 years and passes through 11 companies; a new generation was cleared every 10 months on median.
- 15 of the 329 ancestors have a recall of any class.
What is it indicated for?
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…
Read the full statement (253 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K260945 · printed Nov 6, 2026
Cite this page
510(k) Report. “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).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260945
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026