510(k) · Cleared
ClearedInMode PLUS System
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 Dec 8, 2017 as substantially equivalent to K153568 (Inmode MD, Ltd., 2016) after a 130-day review. Its family tree reaches back 21 generations to 1995. 13 later devices descend from it.
- Decided
- Dec 8, 2017
- Review
- 130 days
- Class
- Class II
- Product code
- PBX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 21 generations to K943450 (1995). 313 ancestors in all, the oldest K800617 (1980). 13 later devices descend from it, 3 citing it directly.
- Root · 21 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 17 generations between
- 3 generations backK142093 V20 SystemViora, Ltd. · 2014
- 2 generations backK150035 V10 systemViora, Ltd. · 2015
- 1 generation backK153568 InMode Plus SystemInmode MD, Ltd. · 2016
- This deviceK172302 InMode PLUS SystemInmode MD, Ltd. · 2017
- Descendant · cites it directly · 8 of its ownK183450 EmBody SystemInmode MD, Ltd. · 2019
- 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 · 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
Show all 21 generations
- Root · 21 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 20 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 19 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 18 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 17 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 16 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 15 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 14 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 13 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 12 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 11 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 10 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 9 generations backK051214 Aluma Skin Renewal SystemLumenis, Inc. · 2005
- 8 generations backK060448 Lumenis One Family of Systems; Lumenis One.Lumenis, Ltd. · 2006
- 7 generations backK072564 Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008
- 6 generations backK082876 Beamax/ Formax Pulsed Light Device FamilySharplight Technologies, Ltd. · 2008
- 5 generations backK111303 Dermatological Treatment Device FamilySharplight Technologies, Ltd. · 2011
- 4 generations backK133837 Viora V-TotalViora, Ltd. · 2014
- 3 generations backK142093 V20 SystemViora, Ltd. · 2014
- 2 generations backK150035 V10 systemViora, Ltd. · 2015
- 1 generation backK153568 InMode Plus SystemInmode MD, Ltd. · 2016
- This deviceK172302 InMode PLUS SystemInmode MD, Ltd. · 2017
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K183450EmBody SystemInmode MD, Ltd. · 2019 · cites it directly8descendants
- K201285InMode Evolve System with the Tone ApplicatorInMode, Ltd. · 2021 · 2 generations on6descendants
- K210877Evolve System with the T3 ApplicatorInMode, Ltd. · 2021 · 2 generations on5descendants
- K221571InMode Multi-systemInMode, Ltd. · 2022 · cites it directly2descendants
- K251632Optimas MAX SystemInMode, Ltd. · 2025 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −21 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −20 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −19 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −18 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −17 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −16 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −15 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −14 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −13 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −12 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −11 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −10 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −9 | K051214 | Aluma Skin Renewal System | Lumenis, Inc. | 2005 | — |
| −8 | K060448 | Lumenis One Family of Systems; Lumenis One. | Lumenis, Ltd. | 2006 | — |
| −7 | K072564 | Alma Lasers Harmony XL Multi-Application Platform | Alma Lasers, Ltd. | 2008 | — |
| −6 | K082876 | Beamax/ Formax Pulsed Light Device Family | Sharplight Technologies, Ltd. | 2008 | — |
| −5 | K111303 | Dermatological Treatment Device Family | Sharplight Technologies, Ltd. | 2011 | — |
| −4 | K133837 | Viora V-Total | Viora, Ltd. | 2014 | — |
| −3 | K142093 | V20 System | Viora, Ltd. | 2014 | — |
| −2 | K150035 | V10 system | Viora, Ltd. | 2015 | — |
| −1 | K153568 | InMode Plus System | Inmode MD, Ltd. | 2016 | — |
| 0 (this device) | K172302 | InMode PLUS System | Inmode MD, Ltd. | 2017 | — |
| +1 | K183450 | EmBody System | Inmode MD, Ltd. | 2019 | — |
| +2 | K201285 | InMode Evolve System with the Tone Applicator | InMode, Ltd. | 2021 | — |
| +2 | K210877 | Evolve System with the T3 Applicator | InMode, Ltd. | 2021 | — |
| +1 | K221571 | InMode Multi-system | InMode, Ltd. | 2022 | — |
| +2 | K251632 | Optimas MAX System | InMode, Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1982 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 2 | 0 |
| 1986 | 3 | 0 |
| 1988 | 1 | 0 |
| 1989 | 3 | 0 |
| 1990 | 3 | 0 |
| 1991 | 10 | 0 |
| 1992 | 4 | 0 |
| 1993 | 9 | 0 |
| 1994 | 15 | 0 |
| 1995 | 15 | 0 |
| 1996 | 20 | 0 |
| 1997 | 23 | 0 |
| 1998 | 21 | 0 |
| 1999 | 12 | 0 |
| 2000 | 25 | 0 |
| 2001 | 27 | 0 |
| 2002 | 32 | 0 |
| 2003 | 23 | 0 |
| 2004 | 15 | 0 |
| 2005 | 10 | 0 |
| 2006 | 3 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2009 | 4 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 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 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 |
|---|---|---|---|
| * | K153568 | InMode Plus SystemSummary page 5…5 === Device Manufacturer 510(k) No. InMode PLUS System InMode MD Ltd. K153568 Device Description: The InMode PLUS System delivers RF energy to gradually heat the skin and subcutaneous tissue. The RF power… | 2016 |
What descends from it? (13)
See all 133 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 22 years and passes through 9 companies; a new generation was cleared every 9 months on median.
- 11 of the 313 ancestors have a recall of any class.
- Of its descendants, K183450 (Inmode MD, Ltd., 2019) has gone furthest, with 8 descendants of its own.
- 2 other devices also cite its predicate K153568.
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. 2017, 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 PLUS System with the PLUS/PLUS90/PLUS-PLUS Hand pieces is indicated for the temporary relief of minor muscle aches and pain. temporary relief of muscle spasm. and temporary improvement of local blood circulation
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/K172302 · printed Nov 5, 2026
Cite this page
510(k) Report. “K172302: InMode PLUS System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K172302
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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