510(k) · Cleared
ClearedEmBody 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 Jun 20, 2019 as substantially equivalent to K131362 (Inmode MD, Ltd., 2013) and 1 other predicate after a 190-day review. Its family tree reaches back 22 generations to 1995. 8 later devices descend from it.
- Decided
- Jun 20, 2019
- Review
- 190 days
- Class
- Class II
- Product code
- PBX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 22 generations to K943450 (1995). 315 ancestors in all, the oldest K800617 (1980). 8 later devices descend from it, 3 citing it directly.
- Root · 22 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 18 generations between
- 3 generations backK150035 V10 systemViora, Ltd. · 2015
- 2 generations backK153568 InMode Plus SystemInmode MD, Ltd. · 2016
- 1 generation backK172302 InMode PLUS SystemInmode MD, Ltd. · 2017
- This deviceK183450 EmBody SystemInmode MD, Ltd. · 2019
- Descendant · cites it directly · 6 of its ownK201285 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 · 2 generations on · 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 · 2 generations on · 0 of its ownK240992 eMVFit (MVF-10M)Weero Co., Ltd. · 2024
Show all 22 generations
- Root · 22 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 21 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 20 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 19 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 18 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 17 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 16 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 15 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 14 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 13 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 12 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 11 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 10 generations backK051214 Aluma Skin Renewal SystemLumenis, Inc. · 2005
- 9 generations backK060448 Lumenis One Family of Systems; Lumenis One.Lumenis, Ltd. · 2006
- 8 generations backK072564 Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008
- 7 generations backK082876 Beamax/ Formax Pulsed Light Device FamilySharplight Technologies, Ltd. · 2008
- 6 generations backK111303 Dermatological Treatment Device FamilySharplight Technologies, Ltd. · 2011
- 5 generations backK133837 Viora V-TotalViora, Ltd. · 2014
- 4 generations backK142093 V20 SystemViora, Ltd. · 2014
- 3 generations backK150035 V10 systemViora, Ltd. · 2015
- 2 generations backK153568 InMode Plus SystemInmode MD, Ltd. · 2016
- 1 generation backK172302 InMode PLUS SystemInmode MD, Ltd. · 2017
- This deviceK183450 EmBody SystemInmode MD, Ltd. · 2019
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K201285InMode Evolve System with the Tone ApplicatorInMode, Ltd. · 2021 · cites it directly6descendants
- K210877Evolve System with the T3 ApplicatorInMode, Ltd. · 2021 · cites it directly5descendants
- K241433EVE Synergy (EVE-20M)Weero Co., Ltd. · 2025 · 2 generations on1descendant
- K253542Apollo Quattro (APQ-10M)Weero Co., Ltd. · 2026 · 2 generations on0descendants
- K240992eMVFit (MVF-10M)Weero Co., Ltd. · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −22 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −21 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −20 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −19 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −18 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −17 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −16 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −15 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −14 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −13 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −12 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −11 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −10 | K051214 | Aluma Skin Renewal System | Lumenis, Inc. | 2005 | — |
| −9 | K060448 | Lumenis One Family of Systems; Lumenis One. | Lumenis, Ltd. | 2006 | — |
| −8 | K072564 | Alma Lasers Harmony XL Multi-Application Platform | Alma Lasers, Ltd. | 2008 | — |
| −7 | K082876 | Beamax/ Formax Pulsed Light Device Family | Sharplight Technologies, Ltd. | 2008 | — |
| −6 | K111303 | Dermatological Treatment Device Family | Sharplight Technologies, Ltd. | 2011 | — |
| −5 | K133837 | Viora V-Total | Viora, Ltd. | 2014 | — |
| −4 | K142093 | V20 System | Viora, Ltd. | 2014 | — |
| −3 | K150035 | V10 system | Viora, Ltd. | 2015 | — |
| −2 | K153568 | InMode Plus System | Inmode MD, Ltd. | 2016 | — |
| −1 | K172302 | InMode PLUS System | Inmode MD, Ltd. | 2017 | — |
| 0 (this device) | K183450 | EmBody System | Inmode MD, Ltd. | 2019 | — |
| +1 | K201285 | InMode Evolve System with the Tone Applicator | InMode, Ltd. | 2021 | — |
| +1 | K210877 | Evolve System with the T3 Applicator | InMode, Ltd. | 2021 | — |
| +2 | K241433 | EVE Synergy (EVE-20M) | Weero Co., Ltd. | 2025 | — |
| +2 | K253542 | Apollo Quattro (APQ-10M) | Weero Co., Ltd. | 2026 | — |
| +2 | K240992 | eMVFit (MVF-10M) | Weero Co., Ltd. | 2024 | — |
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 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 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 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? (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 |
|---|---|---|---|
| * | K131362 | Inmode Wmbody DeviceSummary page 4…t to the following predicate devices. Device Main Predicate Manufacturer 510(k) No. InMode WMbody InMode MD Ltd. K131362 InMode PLUS System InMode MD Ltd. K172302 EmBody System 510(k) file… | 2013 |
| * | K172302 | InMode PLUS SystemSummary page 4…Manufacturer 510(k) No. InMode WMbody InMode MD Ltd. K131362 InMode PLUS System InMode MD Ltd. K172302 EmBody System 510(k) file K183450 Page 05-2… | 2017 |
What descends from it? (8)
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 24 years and passes through 9 companies; a new generation was cleared every 10 months on median.
- 11 of the 315 ancestors have a recall of any class.
- Of its descendants, K201285 (InMode, Ltd., 2021) has gone furthest, with 6 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. 2019, 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 EmBody System with its designated hand pieces is intended for the treatment of the following medical
conditions;
The EmBodyPLUS hand piece 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 EmBodyFX Hand piece is intended for the treatment of the following medical conditions using 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/K183450 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183450: EmBody System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K183450
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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