510(k) · Cleared
ClearedInmode Wmbody Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inmode MD, Ltd. · NUV Massager, Vacuum, Light Induced Heating
Cleared on Oct 8, 2013 as substantially equivalent to K090221 (Viora, Ltd., 2009) after a 148-day review. Its family tree reaches back 16 generations to 1995. 17 later devices descend from it.
- Decided
- Oct 8, 2013
- Review
- 148 days
- Class
- Class II
- Product code
- NUV
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 16 generations to K943450 (1995). 65 ancestors in all, the oldest K800617 (1980). 17 later devices descend from it, 3 citing it directly.
- Root · 16 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 12 generations between
- 3 generations backK071872 VelashapeSyneron Medical, Ltd. · 2007
- 2 generations backK080300 Cutera Multimodal Cellulite Product (Cmmcd)Cutera, Inc. · 2008
- 1 generation backK090221 Reaction SystemViora, Ltd. · 2009
- This deviceK131362 Inmode Wmbody DeviceInmode MD, Ltd. · 2013
- Descendant · cites it directly · 8 of its ownK183450 EmBody SystemInmode MD, Ltd. · 2019
- Descendant · cites it directly · 7 of its ownK160329 InMode System MiniFX HandpieceInmode MD, Ltd. · 2016
- Descendant · 2 generations on · 6 of its ownK201285 InMode Evolve System with the Tone ApplicatorInMode, Ltd. · 2021
- Descendant · 2 generations on · 5 of its ownK210877 Evolve System with the T3 ApplicatorInMode, Ltd. · 2021
- Descendant · 2 generations on · 3 of its ownK170637 sensiFirmEl Global Trade, Ltd. · 2017
Show all 16 generations
- Root · 16 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 15 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 14 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 13 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 12 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 11 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 10 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 9 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 8 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 7 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 6 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 5 generations backK050397 Velasmooth, ShaperSyneron Medical, Ltd. · 2005
- 4 generations backK070092 Modification to Velasmooth, ShaperSyneron Medical, Ltd. · 2007
- 3 generations backK071872 VelashapeSyneron Medical, Ltd. · 2007
- 2 generations backK080300 Cutera Multimodal Cellulite Product (Cmmcd)Cutera, Inc. · 2008
- 1 generation backK090221 Reaction SystemViora, Ltd. · 2009
- This deviceK131362 Inmode Wmbody DeviceInmode MD, Ltd. · 2013
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K183450EmBody SystemInmode MD, Ltd. · 2019 · cites it directly8descendants
- K160329InMode System MiniFX HandpieceInmode MD, Ltd. · 2016 · cites it directly7descendants
- K201285InMode Evolve System with the Tone ApplicatorInMode, Ltd. · 2021 · 2 generations on6descendants
- K210877Evolve System with the T3 ApplicatorInMode, Ltd. · 2021 · 2 generations on5descendants
- K170637sensiFirmEl Global Trade, Ltd. · 2017 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −15 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −14 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −13 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −12 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −11 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −10 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −9 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −8 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −7 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −6 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −5 | K050397 | Velasmooth, Shaper | Syneron Medical, Ltd. | 2005 | — |
| −4 | K070092 | Modification to Velasmooth, Shaper | Syneron Medical, Ltd. | 2007 | — |
| −3 | K071872 | Velashape | Syneron Medical, Ltd. | 2007 | — |
| −2 | K080300 | Cutera Multimodal Cellulite Product (Cmmcd) | Cutera, Inc. | 2008 | — |
| −1 | K090221 | Reaction System | Viora, Ltd. | 2009 | — |
| 0 (this device) | K131362 | Inmode Wmbody Device | Inmode MD, Ltd. | 2013 | — |
| +1 | K183450 | EmBody System | Inmode MD, Ltd. | 2019 | — |
| +1 | K160329 | InMode System MiniFX Handpiece | Inmode MD, Ltd. | 2016 | — |
| +2 | K201285 | InMode Evolve System with the Tone Applicator | InMode, Ltd. | 2021 | — |
| +2 | K210877 | Evolve System with the T3 Applicator | InMode, Ltd. | 2021 | — |
| +2 | K170637 | sensiFirm | El Global Trade, Ltd. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1996 | 9 | 0 |
| 1997 | 6 | 0 |
| 1998 | 4 | 0 |
| 1999 | 3 | 0 |
| 2000 | 4 | 0 |
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 4 | 0 |
| 2026 | 1 | 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 NUV? 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 NUV device
- #1 K261582 Vacuum Roller RF Slimming Device for Medical…score 16.7 · 17 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 |
|---|---|---|---|
| * | K090221 | Reaction SystemSummary page 1…t to the following predicate devices. Manufacturer Device : :510(k) No. Viora Ltd. Reaction System K090221 A.STEIN - REGULATORY AFFAIRS CONSULTING LTD APPENDIX A Device Descriptio… | 2009 |
What descends from it? (17)
See all 173 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 18 years and passes through 6 companies; a new generation was cleared every 9 months on median.
- 4 of the 65 ancestors have a recall of any class.
- Of its descendants, K183450 (Inmode MD, Ltd., 2019) has gone furthest, with 8 descendants of its own.
- 6 other devices also cite its predicate K090221.
How does its category compare?
All NUV devicesNUV Massager, Vacuum, Light Induced Heating: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · NUV
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · NUV
99in 2009
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NUV
No recall names NUV since 2007.
Adverse event reports per year · NUV
1in 2020
MAUDE reports naming product code NUV, 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 | 2 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 4 | 99 | 0 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 3 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 3 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The InMode WIMbody device is intended for the treatment of the following medical conditions, using the WIMbady applicator fr delivering non-thermal RW combined with
message:
Relief of minor muscle aches and pains, relief of muscle spasma, temporary
improvement of blood circulation; and
Temporary reduction in the appearance of cellulite.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131362 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131362: Inmode Wmbody Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131362
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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