510(k) · Cleared
ClearedInMode Evolve System with the Tone Applicator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
InMode, Ltd. · IPF Stimulator, Muscle, Powered
Cleared on Mar 5, 2021 as substantially equivalent to K192249 (InMode, Ltd., 2019) and 1 other predicate after a 296-day review. Its family tree reaches back 23 generations to 1995. 6 later devices descend from it.
- Decided
- Mar 5, 2021
- Review
- 296 days
- Class
- Class II
- Product code
- IPF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 23 generations to K943450 (1995). 322 ancestors in all, the oldest K800617 (1980). 6 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 backK153568 InMode Plus SystemInmode MD, Ltd. · 2016
- 2 generations backK172302 InMode PLUS SystemInmode MD, Ltd. · 2017
- 1 generation backK183450 EmBody SystemInmode MD, Ltd. · 2019
- This deviceK201285 InMode Evolve System with the Tone ApplicatorInMode, Ltd. · 2021
- Descendant · cites it directly · 5 of its ownK210877 Evolve System with the T3 ApplicatorInMode, Ltd. · 2021
- Descendant · cites it directly · 1 of its ownK241433 EVE Synergy (EVE-20M)Weero Co., Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK253542 Apollo Quattro (APQ-10M)Weero Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK240992 eMVFit (MVF-10M)Weero Co., Ltd. · 2024
- Descendant · 2 generations on · 0 of its ownK230167 BACK 4Swims America Corp · 2023
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 backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 12 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 11 generations backK051214 Aluma Skin Renewal SystemLumenis, Inc. · 2005
- 10 generations backK060448 Lumenis One Family of Systems; Lumenis One.Lumenis, Ltd. · 2006
- 9 generations backK072564 Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008
- 8 generations backK082876 Beamax/ Formax Pulsed Light Device FamilySharplight Technologies, Ltd. · 2008
- 7 generations backK111303 Dermatological Treatment Device FamilySharplight Technologies, Ltd. · 2011
- 6 generations backK133837 Viora V-TotalViora, Ltd. · 2014
- 5 generations backK142093 V20 SystemViora, Ltd. · 2014
- 4 generations backK150035 V10 systemViora, Ltd. · 2015
- 3 generations backK153568 InMode Plus SystemInmode MD, Ltd. · 2016
- 2 generations backK172302 InMode PLUS SystemInmode MD, Ltd. · 2017
- 1 generation backK183450 EmBody SystemInmode MD, Ltd. · 2019
- This deviceK201285 InMode Evolve System with the Tone ApplicatorInMode, Ltd. · 2021
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K210877Evolve System with the T3 ApplicatorInMode, Ltd. · 2021 · cites it directly5descendants
- K241433EVE Synergy (EVE-20M)Weero Co., Ltd. · 2025 · cites it directly1descendant
- K253542Apollo Quattro (APQ-10M)Weero Co., Ltd. · 2026 · 2 generations on0descendants
- K240992eMVFit (MVF-10M)Weero Co., Ltd. · 2024 · cites it directly0descendants
- K230167BACK 4Swims America Corp · 2023 · 2 generations on0descendants
View 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 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −12 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −11 | K051214 | Aluma Skin Renewal System | Lumenis, Inc. | 2005 | — |
| −10 | K060448 | Lumenis One Family of Systems; Lumenis One. | Lumenis, Ltd. | 2006 | — |
| −9 | K072564 | Alma Lasers Harmony XL Multi-Application Platform | Alma Lasers, Ltd. | 2008 | — |
| −8 | K082876 | Beamax/ Formax Pulsed Light Device Family | Sharplight Technologies, Ltd. | 2008 | — |
| −7 | K111303 | Dermatological Treatment Device Family | Sharplight Technologies, Ltd. | 2011 | — |
| −6 | K133837 | Viora V-Total | Viora, Ltd. | 2014 | — |
| −5 | K142093 | V20 System | Viora, Ltd. | 2014 | — |
| −4 | K150035 | V10 system | Viora, Ltd. | 2015 | — |
| −3 | K153568 | InMode Plus System | Inmode MD, Ltd. | 2016 | — |
| −2 | K172302 | InMode PLUS System | Inmode MD, Ltd. | 2017 | — |
| −1 | K183450 | EmBody System | Inmode MD, Ltd. | 2019 | — |
| 0 (this device) | K201285 | InMode Evolve System with the Tone Applicator | InMode, Ltd. | 2021 | — |
| +1 | K210877 | Evolve System with the T3 Applicator | InMode, Ltd. | 2021 | — |
| +1 | K241433 | EVE Synergy (EVE-20M) | Weero Co., Ltd. | 2025 | — |
| +2 | K253542 | Apollo Quattro (APQ-10M) | Weero Co., Ltd. | 2026 | — |
| +1 | K240992 | eMVFit (MVF-10M) | Weero Co., Ltd. | 2024 | — |
| +2 | K230167 | BACK 4 | Swims America Corp | 2023 | — |
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 | 17 | 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 | 16 | 0 |
| 2005 | 10 | 0 |
| 2006 | 3 | 0 |
| 2007 | 4 | 0 |
| 2008 | 1 | 0 |
| 2009 | 4 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2019 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 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 IPF? 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 IPF device
- #1 K241433 EVE Synergy (EVE-20M)score 19.7 · 25 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K192249 | InMode System with Tone ApplicatorSummary page 4…Device 510(k) No. Main Predicate InMode System with the Tone Applicator InMode Ltd. K192249 Reference Predicate The EVOLVE System InMode Ltd. K… | 2019 |
| * | K183450 | EmBody SystemSummary page 4…InMode Ltd. K192249 Reference Predicate The EVOLVE System InMode Ltd. K183450 527 EVOLVE System with the Tone Applicator 510(k) file… | 2019 |
What descends from it? (6)
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 26 years and passes through 10 companies; a new generation was cleared every 10 months on median.
- 11 of the 322 ancestors have a recall of any class.
- Of its descendants, K210877 (InMode, Ltd., 2021) has gone furthest, with 5 descendants of its own.
- 1 other device also cites its predicate K192249.
How does its category compare?
All IPF devicesIPF Stimulator, Muscle, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · IPF
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IPF
257in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IPF
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IPF
8in 2025
MAUDE reports naming product code IPF, 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 | 8 | 143 | 0 | 11 |
| 2008 | 6 | 140 | 1 | 213 |
| 2009 | 7 | 216 | 0 | 150 |
| 2010 | 4 | 121 | 0 | 14 |
| 2011 | 4 | 275 | 1 | 25 |
| 2012 | 4 | 269 | 3 | 16 |
| 2013 | 10 | 180 | 0 | 6 |
| 2014 | 4 | 264 | 0 | 19 |
| 2015 | 3 | 43 | 0 | 11 |
| 2016 | 7 | 113 | 0 | 8 |
| 2017 | 5 | 110 | 0 | 2 |
| 2018 | 5 | 73 | 0 | 3 |
| 2019 | 4 | 133 | 0 | 10 |
| 2020 | 9 | 121 | 0 | 13 |
| 2021 | 15 | 98 | 0 | 3 |
| 2022 | 7 | 108 | 0 | 4 |
| 2023 | 9 | 255 | 1 | 8 |
| 2024 | 7 | 201 | 0 | 5 |
| 2025 | 3 | 257 | 0 | 8 |
| 2026 | 3 | 206 | 0 | — |
What is it indicated for?
The EVOLVE System with the Tone Applicator is an electro-muscle and transcutaneous nerve stimulation device for the treatment of different body areas.
The EVOLVE System with Tone Applicator is designed to operate in two modes — EMS and TENS.
In EMS mode it is used for:
» Relaxation of muscle spasms
* Prevention or retardation of disuse atrophy
» Increasing local blood circulation
* Muscle re-education
* Maintaining or increasing range of motion
» Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
And in TENS mode is intended for
» Symptomatic relief and management of chronic, intractable pain
* Post-surgical acute pain
* Post-trauma acute pain
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/K201285 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201285: InMode Evolve System with the Tone Applicator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201285
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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