510(k) · Cleared
ClearedInMode System MiniFX Handpiece
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inmode MD, Ltd. · PBX Massager, Vacuum, Radio Frequency Induced Heat
Cleared on Aug 19, 2016 as substantially equivalent to K131362 (Inmode MD, Ltd., 2013) after a 196-day review. Its family tree reaches back 17 generations to 1995. 7 later devices descend from it.
- Decided
- Aug 19, 2016
- Review
- 196 days
- Class
- Class II
- Product code
- PBX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 17 generations to K943450 (1995). 66 ancestors in all, the oldest K800617 (1980). 7 later devices descend from it, 3 citing it directly.
- Root · 17 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 13 generations between
- 3 generations backK080300 Cutera Multimodal Cellulite Product (Cmmcd)Cutera, Inc. · 2008
- 2 generations backK090221 Reaction SystemViora, Ltd. · 2009
- 1 generation backK131362 Inmode Wmbody DeviceInmode MD, Ltd. · 2013
- This deviceK160329 InMode System MiniFX HandpieceInmode MD, Ltd. · 2016
- Descendant · cites it directly · 3 of its ownK170637 sensiFirmEl Global Trade, Ltd. · 2017
- Descendant · cites it directly · 2 of its ownK221571 InMode Multi-systemInMode, Ltd. · 2022
- Descendant · 2 generations on · 1 of its ownK251632 Optimas MAX SystemInMode, Ltd. · 2025
- Descendant · cites it directly · 1 of its ownK181095 RF-ReliefEl Global Trade, Ltd. · 2018
- Descendant · 2 generations on · 0 of its ownK250734 OptiLUV DevicePollogen, Ltd. · 2025
Show all 17 generations
- Root · 17 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 16 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 15 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 14 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 13 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 12 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 11 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 10 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 9 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 8 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 7 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 6 generations backK050397 Velasmooth, ShaperSyneron Medical, Ltd. · 2005
- 5 generations backK070092 Modification to Velasmooth, ShaperSyneron Medical, Ltd. · 2007
- 4 generations backK071872 VelashapeSyneron Medical, Ltd. · 2007
- 3 generations backK080300 Cutera Multimodal Cellulite Product (Cmmcd)Cutera, Inc. · 2008
- 2 generations backK090221 Reaction SystemViora, Ltd. · 2009
- 1 generation backK131362 Inmode Wmbody DeviceInmode MD, Ltd. · 2013
- This deviceK160329 InMode System MiniFX HandpieceInmode MD, Ltd. · 2016
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K170637sensiFirmEl Global Trade, Ltd. · 2017 · cites it directly3descendants
- K221571InMode Multi-systemInMode, Ltd. · 2022 · cites it directly2descendants
- K251632Optimas MAX SystemInMode, Ltd. · 2025 · 2 generations on1descendant
- K181095RF-ReliefEl Global Trade, Ltd. · 2018 · cites it directly1descendant
- K250734OptiLUV DevicePollogen, Ltd. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −16 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −15 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −14 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −13 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −12 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −11 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −10 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −9 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −8 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −7 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −6 | K050397 | Velasmooth, Shaper | Syneron Medical, Ltd. | 2005 | — |
| −5 | K070092 | Modification to Velasmooth, Shaper | Syneron Medical, Ltd. | 2007 | — |
| −4 | K071872 | Velashape | Syneron Medical, Ltd. | 2007 | — |
| −3 | K080300 | Cutera Multimodal Cellulite Product (Cmmcd) | Cutera, Inc. | 2008 | — |
| −2 | K090221 | Reaction System | Viora, Ltd. | 2009 | — |
| −1 | K131362 | Inmode Wmbody Device | Inmode MD, Ltd. | 2013 | — |
| 0 (this device) | K160329 | InMode System MiniFX Handpiece | Inmode MD, Ltd. | 2016 | — |
| +1 | K170637 | sensiFirm | El Global Trade, Ltd. | 2017 | — |
| +1 | K221571 | InMode Multi-system | InMode, Ltd. | 2022 | — |
| +2 | K251632 | Optimas MAX System | InMode, Ltd. | 2025 | — |
| +1 | K181095 | RF-Relief | El Global Trade, Ltd. | 2018 | — |
| +2 | K250734 | OptiLUV Device | Pollogen, Ltd. | 2025 | — |
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 |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2022 | 2 | 0 |
| 2025 | 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 PBX? 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 PBX device
- #1 K210877 Evolve System with the T3 Applicatorscore 23.6 · 24 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 |
|---|---|---|---|
| * | K131362 | Inmode Wmbody DeviceSummary page 4…nt to the following predicate device: Device Manufacturer 510(k) No. InMode WMBody InMode MD Ltd. K131362 Page 6-1 Device Description: The InMode System with the MiniFX Handpiece… | 2013 |
What descends from it? (7)
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 21 years and passes through 6 companies; a new generation was cleared every 9 months on median.
- 4 of the 66 ancestors have a recall of any class.
- Of its descendants, K170637 (El Global Trade, Ltd., 2017) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K131362.
How does its category compare?
All PBX devicesPBX Massager, Vacuum, Radio Frequency Induced Heat: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · PBX
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PBX
200in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PBX
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PBX
4in 2025
MAUDE reports naming product code PBX, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 12 |
| 2014 | 2 | — | 0 | 4 |
| 2015 | 5 | 181 | 0 | 0 |
| 2016 | 7 | 130 | 0 | 2 |
| 2017 | 6 | 132 | 1 | 1 |
| 2018 | 3 | 89 | 0 | 1 |
| 2019 | 8 | 147 | 0 | 4 |
| 2020 | 8 | 134 | 0 | 4 |
| 2021 | 6 | 169 | 0 | 8 |
| 2022 | 7 | 308 | 0 | 7 |
| 2023 | 9 | 227 | 0 | 7 |
| 2024 | 6 | 130 | 0 | 2 |
| 2025 | 7 | 200 | 0 | 4 |
| 2026 | 6 | 225 | 0 | — |
What is it indicated for?
The InMode System with the WMbody Handpiece and the MiniFX Handpiece is intended for the treatment of the following medical conditions using non thermal RF combined with massage:
Relief of' minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation.
Temporary reduction in the appearance of cellulite.
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/K160329 · printed Nov 5, 2026
Cite this page
510(k) Report. “K160329: InMode System MiniFX Handpiece.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K160329
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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