510(k) · Cleared
ClearedInMode RF System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
InMode, Ltd. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Jul 24, 2024 as substantially equivalent to K233642 (InMode, Ltd., 2024) after a 125-day review. Its family tree reaches back 23 generations to 1995. 3 later devices descend from it.
- Decided
- Jul 24, 2024
- Review
- 125 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 23 generations to K943450 (1995). 264 ancestors in all, the oldest K800617 (1980). 3 later devices descend from it, 3 citing it directly.
- Root · 23 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 19 generations between
- 3 generations backK200947 InMode System with the Morhpeus8 ApplicatorsInMode, Ltd. · 2020
- 2 generations backK231790 The InMode System with the Morpheus8 ApplicatorsInMode, Ltd. · 2023
- 1 generation backK233642 InMode RF SystemInMode, Ltd. · 2024
- This deviceK240780 InMode RF SystemInMode, Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK251435 InbellaIgnite RF SystemInbella Medical, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK251254 Ignite RF SystemInMode, Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK243737 Inbella RF SystemInbella Medical, Inc. · 2025
Show all 23 generations
- Root · 23 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 22 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 21 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 20 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 19 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 18 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 17 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 16 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 15 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 14 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 13 generations backK032088 Modification to Thermacool TC SystemThermage, Inc. · 2003
- 12 generations backK052778 Thermage Thermacool Skin MarketingThermage, Inc. · 2005
- 11 generations backK060948 Portrait PSR3Rhytec Incorporated · 2006 · Recalled
- 10 generations backK071786 Portrait PSRRhytec Incorporated · 2007
- 9 generations backK072394 Portrait Stand-OffRhytec Incorporated · 2007
- 8 generations backK073572 Matrix RF ApplicatorSyneron Medical, Ltd. · 2008
- 7 generations backK101510 Fractional Skin Resurfacing (FSR) ApplicatorEndymed Medical, Ltd. · 2011
- 6 generations backK130501 IntensifEndymed Medical, Ltd. · 2014
- 5 generations backK180189 InMode System with Fractora3D/3D-90 ApplicatorsInmode MD, Ltd. · 2018
- 4 generations backK192695 InMode System with the Morpheus8 (Fractora) ApplicatorsInmode MD, Ltd. · 2019
- 3 generations backK200947 InMode System with the Morhpeus8 ApplicatorsInMode, Ltd. · 2020
- 2 generations backK231790 The InMode System with the Morpheus8 ApplicatorsInMode, Ltd. · 2023
- 1 generation backK233642 InMode RF SystemInMode, Ltd. · 2024
- This deviceK240780 InMode RF SystemInMode, Ltd. · 2024
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −23 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −22 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −21 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −20 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −19 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −18 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −17 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −16 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −15 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −14 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −13 | K032088 | Modification to Thermacool TC System | Thermage, Inc. | 2003 | — |
| −12 | K052778 | Thermage Thermacool Skin Marketing | Thermage, Inc. | 2005 | — |
| −11 | K060948 | Portrait PSR3 | Rhytec Incorporated | 2006 | 1 |
| −10 | K071786 | Portrait PSR | Rhytec Incorporated | 2007 | — |
| −9 | K072394 | Portrait Stand-Off | Rhytec Incorporated | 2007 | — |
| −8 | K073572 | Matrix RF Applicator | Syneron Medical, Ltd. | 2008 | — |
| −7 | K101510 | Fractional Skin Resurfacing (FSR) Applicator | Endymed Medical, Ltd. | 2011 | — |
| −6 | K130501 | Intensif | Endymed Medical, Ltd. | 2014 | — |
| −5 | K180189 | InMode System with Fractora3D/3D-90 Applicators | Inmode MD, Ltd. | 2018 | — |
| −4 | K192695 | InMode System with the Morpheus8 (Fractora) Applicators | Inmode MD, Ltd. | 2019 | — |
| −3 | K200947 | InMode System with the Morhpeus8 Applicators | InMode, Ltd. | 2020 | — |
| −2 | K231790 | The InMode System with the Morpheus8 Applicators | InMode, Ltd. | 2023 | — |
| −1 | K233642 | InMode RF System | InMode, Ltd. | 2024 | — |
| 0 (this device) | K240780 | InMode RF System | InMode, Ltd. | 2024 | — |
| +1 | K251435 | InbellaIgnite RF System | Inbella Medical, Inc. | 2026 | — |
| +1 | K251254 | Ignite RF System | InMode, Ltd. | 2026 | — |
| +1 | K243737 | Inbella RF System | Inbella Medical, Inc. | 2025 | — |
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 | 15 | 0 |
| 1995 | 14 | 0 |
| 1996 | 20 | 0 |
| 1997 | 22 | 0 |
| 1998 | 14 | 0 |
| 1999 | 11 | 0 |
| 2000 | 21 | 0 |
| 2001 | 23 | 0 |
| 2002 | 28 | 0 |
| 2003 | 23 | 0 |
| 2004 | 10 | 0 |
| 2005 | 5 | 0 |
| 2006 | 1 | 0 |
| 2007 | 4 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
| 2026 | 2 | 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 GEI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GEI device
- #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K233642 | InMode RF SystemSummary page 4…00 Israel Classification Name: Electrosurgical cutting and coagulation device and accessories Regulation Number: 878.4400 Product Code: GEI Predicate Devices K233642 - InMode RF System - Product Code: GEI Intended Use / Indications for Use The InMode RF System is indicated for use in d… | 2024 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 29 years and passes through 7 companies; a new generation was cleared every 11 months on median.
- 10 of the 264 ancestors have a recall of any class.
- Of its descendants, K251435 (Inbella Medical, Inc., 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · GEI
52in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEI
113in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEI
4in 2025
Class I (14 since 2007) Class II/III not classified
Adverse event reports per year · GEI
7,592in 2025
MAUDE reports naming product code GEI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 50 | 51 | 21 | 2,795 |
| 2008 | 61 | 71 | 19 | 2,556 |
| 2009 | 42 | 130 | 27 | 3,591 |
| 2010 | 46 | 109 | 51 | 3,377 |
| 2011 | 35 | 135 | 32 | 4,463 |
| 2012 | 39 | 133 | 30 | 5,216 |
| 2013 | 48 | 136 | 13 | 4,897 |
| 2014 | 49 | 103 | 3 | 4,908 |
| 2015 | 47 | 123 | 4 | 4,936 |
| 2016 | 64 | 108 | 3 | 5,616 |
| 2017 | 52 | 72 | 2 | 6,073 |
| 2018 | 47 | 93 | 6 | 6,545 |
| 2019 | 48 | 93 | 5 | 7,067 |
| 2020 | 59 | 105 | 1 | 6,490 |
| 2021 | 46 | 146 | 6 | 6,354 |
| 2022 | 55 | 150 | 49 | 6,103 |
| 2023 | 65 | 104 | 27 (4) | 7,176 |
| 2024 | 59 | 125 | 22 (10) | 7,897 |
| 2025 | 52 | 113 | 4 | 7,592 |
| 2026 | 43 | 183 | 8 | — |
What is it indicated for?
The InMode RF System is indicated for use in dermatological and general surgical procedures
where coagulation/contraction of soft tissue or hemostasis is needed.
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/K240780 · printed Nov 4, 2026
Cite this page
510(k) Report. “K240780: InMode RF System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K240780
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026