510(k) · Cleared
ClearedEvolve System with the T3 Applicator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
InMode, Ltd. · PBX Massager, Vacuum, Radio Frequency Induced Heat
Cleared on Jul 19, 2021 as substantially equivalent to K201285 (InMode, Ltd., 2021) and 1 other predicate after a 117-day review. Its family tree reaches back 24 generations to 1995. 5 later devices descend from it.
- Decided
- Jul 19, 2021
- Review
- 117 days
- Class
- Class II
- Product code
- PBX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 24 generations to K943450 (1995). 323 ancestors in all, the oldest K800617 (1980). 5 later devices descend from it, 5 citing it directly.
- Root · 24 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 20 generations between
- 3 generations backK172302 InMode PLUS SystemInmode MD, Ltd. · 2017
- 2 generations backK183450 EmBody SystemInmode MD, Ltd. · 2019
- 1 generation backK201285 InMode Evolve System with the Tone ApplicatorInMode, Ltd. · 2021
- This deviceK210877 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 · cites it directly · 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 · cites it directly · 0 of its ownK230167 BACK 4Swims America Corp · 2023
- Descendant · cites it directly · 0 of its ownK230037 BACK 3Swims America Corp · 2023
Show all 24 generations
- Root · 24 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 23 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 22 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 21 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 20 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 19 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 18 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 17 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 16 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 15 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 14 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 13 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 12 generations backK051214 Aluma Skin Renewal SystemLumenis, Inc. · 2005
- 11 generations backK060448 Lumenis One Family of Systems; Lumenis One.Lumenis, Ltd. · 2006
- 10 generations backK072564 Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008
- 9 generations backK082876 Beamax/ Formax Pulsed Light Device FamilySharplight Technologies, Ltd. · 2008
- 8 generations backK111303 Dermatological Treatment Device FamilySharplight Technologies, Ltd. · 2011
- 7 generations backK133837 Viora V-TotalViora, Ltd. · 2014
- 6 generations backK142093 V20 SystemViora, Ltd. · 2014
- 5 generations backK150035 V10 systemViora, Ltd. · 2015
- 4 generations backK153568 InMode Plus SystemInmode MD, Ltd. · 2016
- 3 generations backK172302 InMode PLUS SystemInmode MD, Ltd. · 2017
- 2 generations backK183450 EmBody SystemInmode MD, Ltd. · 2019
- 1 generation backK201285 InMode Evolve System with the Tone ApplicatorInMode, Ltd. · 2021
- This deviceK210877 Evolve System with the T3 ApplicatorInMode, Ltd. · 2021
Most influential descendants
Showing 5 of 5 · See all- K241433EVE Synergy (EVE-20M)Weero Co., Ltd. · 2025 · cites it directly1descendant
- K253542Apollo Quattro (APQ-10M)Weero Co., Ltd. · 2026 · cites it directly0descendants
- K240992eMVFit (MVF-10M)Weero Co., Ltd. · 2024 · cites it directly0descendants
- K230167BACK 4Swims America Corp · 2023 · cites it directly0descendants
- K230037BACK 3Swims America Corp · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −24 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −23 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −22 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −21 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −20 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −19 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −18 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −17 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −16 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −15 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −14 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −13 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −12 | K051214 | Aluma Skin Renewal System | Lumenis, Inc. | 2005 | — |
| −11 | K060448 | Lumenis One Family of Systems; Lumenis One. | Lumenis, Ltd. | 2006 | — |
| −10 | K072564 | Alma Lasers Harmony XL Multi-Application Platform | Alma Lasers, Ltd. | 2008 | — |
| −9 | K082876 | Beamax/ Formax Pulsed Light Device Family | Sharplight Technologies, Ltd. | 2008 | — |
| −8 | K111303 | Dermatological Treatment Device Family | Sharplight Technologies, Ltd. | 2011 | — |
| −7 | K133837 | Viora V-Total | Viora, Ltd. | 2014 | — |
| −6 | K142093 | V20 System | Viora, Ltd. | 2014 | — |
| −5 | K150035 | V10 system | Viora, Ltd. | 2015 | — |
| −4 | K153568 | InMode Plus System | Inmode MD, Ltd. | 2016 | — |
| −3 | K172302 | InMode PLUS System | Inmode MD, Ltd. | 2017 | — |
| −2 | K183450 | EmBody System | Inmode MD, Ltd. | 2019 | — |
| −1 | K201285 | InMode Evolve System with the Tone Applicator | InMode, Ltd. | 2021 | — |
| 0 (this device) | K210877 | Evolve System with the T3 Applicator | InMode, Ltd. | 2021 | — |
| +1 | K241433 | EVE Synergy (EVE-20M) | Weero Co., Ltd. | 2025 | — |
| +1 | K253542 | Apollo Quattro (APQ-10M) | Weero Co., Ltd. | 2026 | — |
| +1 | K240992 | eMVFit (MVF-10M) | Weero Co., Ltd. | 2024 | — |
| +1 | K230167 | BACK 4 | Swims America Corp | 2023 | — |
| +1 | K230037 | BACK 3 | 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 |
|---|---|---|
| 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 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 K243223 Multiple therapy aesthetic treatment device…score 17.8 · 20 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 |
|---|---|---|---|
| * | K201285 | InMode Evolve System with the Tone ApplicatorSummary page 5…e devices. Manufacturer Device 510(k) No. Primary Predicate Evolve System with the Tone InMode Ltd. K201285 Applicator Secondary Predicate The EVOLVE System InMode Ltd. K183450 Device Description: Th… | 2021 |
| * | K183450 | EmBody SystemSummary page 5…Evolve System with the Tone InMode Ltd. K201285 Applicator Secondary Predicate The EVOLVE System InMode Ltd. K183450 Device Description: The Evolve System with the T3 Applicator is designed to deliver non-thermal RF energy and electro-muscle an… | 2019 |
What descends from it? (5)
5 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 323 ancestors have a recall of any class.
- Of its descendants, K241433 (Weero Co., Ltd., 2025) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K201285.
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. 2021, 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 Evolve System with the T3 Applicator employs RF technology or EMS-TENS technology for the treatment of selected medical conditions. The T3 Applicator in RF mode is intended for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasm, and temporary improvement of local blood circulation. The T3 Applicator in EMS mode is intended for: * Relaxation of muscle spasms * Prevention or retardation of disuse atrophy * Increasing…
Read the full statement (139 words)
The Evolve System with the T3 Applicator employs RF technology or EMS-TENS technology for the treatment of
selected medical conditions.
The T3 Applicator in RF mode is intended for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasm, and temporary improvement of local blood circulation.
The T3 Applicator in EMS mode is intended 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
The T3 Applicator in TENS mode is intended for:
» Symptomatic relief and management of chronic, intractable pain
* Post-surgical acute pain
* Post-trauma acute pain
The RF treatment mode and EMS/TENS mode should not be used in combination or sequentially.
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/K210877 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210877: Evolve System with the T3 Applicator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210877
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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