510(k) · Cleared
ClearedInMode System with Fractora3D/3D-90 Applicators
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inmode MD, Ltd. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Jun 1, 2018 as substantially equivalent to K130501 (Endymed Medical, Ltd., 2014) after a 129-day review. Its family tree reaches back 18 generations to 1995. 38 later devices descend from it.
- Decided
- Jun 1, 2018
- Review
- 129 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 18 generations to K943450 (1995). 257 ancestors in all, the oldest K800617 (1980). 38 later devices descend from it, 4 citing it directly.
- Root · 18 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 14 generations between
- 3 generations backK073572 Matrix RF ApplicatorSyneron Medical, Ltd. · 2008
- 2 generations backK101510 Fractional Skin Resurfacing (FSR) ApplicatorEndymed Medical, Ltd. · 2011
- 1 generation backK130501 IntensifEndymed Medical, Ltd. · 2014
- This deviceK180189 InMode System with Fractora3D/3D-90 ApplicatorsInmode MD, Ltd. · 2018
- Descendant · cites it directly · 20 of its ownK192545 PotenzaJeisys Medical Incorporated · 2020
- Descendant · cites it directly · 16 of its ownK192695 InMode System with the Morpheus8 (Fractora) ApplicatorsInmode MD, Ltd. · 2019
- Descendant · 2 generations on · 15 of its ownK200947 InMode System with the Morhpeus8 ApplicatorsInMode, Ltd. · 2020
- Descendant · 3 generations on · 10 of its ownK231790 The InMode System with the Morpheus8 ApplicatorsInMode, Ltd. · 2023
- Descendant · 2 generations on · 9 of its ownK201685 PotenzaJeisys Medical, Inc. · 2021
Show all 18 generations
- Root · 18 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 17 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 16 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 15 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 14 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 13 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 12 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 11 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 10 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 9 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 8 generations backK032088 Modification to Thermacool TC SystemThermage, Inc. · 2003
- 7 generations backK052778 Thermage Thermacool Skin MarketingThermage, Inc. · 2005
- 6 generations backK060948 Portrait PSR3Rhytec Incorporated · 2006 · Recalled
- 5 generations backK071786 Portrait PSRRhytec Incorporated · 2007
- 4 generations backK072394 Portrait Stand-OffRhytec Incorporated · 2007
- 3 generations backK073572 Matrix RF ApplicatorSyneron Medical, Ltd. · 2008
- 2 generations backK101510 Fractional Skin Resurfacing (FSR) ApplicatorEndymed Medical, Ltd. · 2011
- 1 generation backK130501 IntensifEndymed Medical, Ltd. · 2014
- This deviceK180189 InMode System with Fractora3D/3D-90 ApplicatorsInmode MD, Ltd. · 2018
Showing 5 of 38 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 38 · See all- K192545PotenzaJeisys Medical Incorporated · 2020 · cites it directly20descendants
- K192695InMode System with the Morpheus8 (Fractora) ApplicatorsInmode MD, Ltd. · 2019 · cites it directly16descendants
- K200947InMode System with the Morhpeus8 ApplicatorsInMode, Ltd. · 2020 · 2 generations on15descendants
- K231790The InMode System with the Morpheus8 ApplicatorsInMode, Ltd. · 2023 · 3 generations on10descendants
- K201685PotenzaJeisys Medical, Inc. · 2021 · 2 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −17 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −16 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −15 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −14 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −13 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −12 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −11 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −10 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −9 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −8 | K032088 | Modification to Thermacool TC System | Thermage, Inc. | 2003 | — |
| −7 | K052778 | Thermage Thermacool Skin Marketing | Thermage, Inc. | 2005 | — |
| −6 | K060948 | Portrait PSR3 | Rhytec Incorporated | 2006 | 1 |
| −5 | K071786 | Portrait PSR | Rhytec Incorporated | 2007 | — |
| −4 | K072394 | Portrait Stand-Off | Rhytec Incorporated | 2007 | — |
| −3 | K073572 | Matrix RF Applicator | Syneron Medical, Ltd. | 2008 | — |
| −2 | K101510 | Fractional Skin Resurfacing (FSR) Applicator | Endymed Medical, Ltd. | 2011 | — |
| −1 | K130501 | Intensif | Endymed Medical, Ltd. | 2014 | — |
| 0 (this device) | K180189 | InMode System with Fractora3D/3D-90 Applicators | Inmode MD, Ltd. | 2018 | — |
| +1 | K192545 | Potenza | Jeisys Medical Incorporated | 2020 | — |
| +1 | K192695 | InMode System with the Morpheus8 (Fractora) Applicators | Inmode MD, Ltd. | 2019 | — |
| +2 | K200947 | InMode System with the Morhpeus8 Applicators | InMode, Ltd. | 2020 | — |
| +3 | K231790 | The InMode System with the Morpheus8 Applicators | InMode, Ltd. | 2023 | — |
| +2 | K201685 | Potenza | Jeisys Medical, Inc. | 2021 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 3 | 0 |
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2024 | 10 | 0 |
| 2025 | 9 | 0 |
| 2026 | 7 | 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 |
|---|---|---|---|
| * | K130501 | IntensifSummary page 4…owing predicate device; Manufacturer Device 510(k) No. EndyMed Medical Intensif Applicator K130501 Ltd. InMode MD Ltd. InMode FRF Applicator K151273 140… | 2014 |
| † | K151273 | InMode FRF Applicator | 2016 |
| † | K102461 | Fractora | 2011 |
| † | K082451 | Stryker Videoscope | 2008 |
| † | K142438 | Nerve Monitoring Cable System | 2015 |
| † | K151019 | SternaLock® 360 Sternal Closure System | 2015 |
| † | K081365 | SJM Confirm Model DM2100 Implantable Cardiac Monitor and Model DM2100A Patient Activator | 2008 |
What descends from it? (38)
See all 384 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 23 years and passes through 6 companies; a new generation was cleared every 11 months on median.
- 10 of the 257 ancestors have a recall of any class.
- Of its descendants, K192545 (Jeisys Medical Incorporated, 2020) has gone furthest, with 20 descendants of its own.
- 3 other devices also cite its predicate K130501.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 System with the Fractora3D/3D-90 Applicators is intended for use in Dermatological and General Surgical procedures for Electrocoagulation and Homeostasis.
At higher energy levels greater than 62 mJ/pin, use of the FRF applicator is limited to Skin Types I-IV.
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/K180189 · printed Nov 4, 2026
Cite this page
510(k) Report. “K180189: InMode System with Fractora3D/3D-90 Applicators.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K180189
Report an extraction error
Are you the manufacturer?
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