510(k) · Cleared
ClearedInMode RF Multi-System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
InMode, Ltd. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Jul 22, 2020 as substantially equivalent to K182325 (Inmode MD, Ltd., 2018) after an 84-day review. Its family tree reaches back 2 generations to 2017. 8 later devices descend from it.
- Decided
- Jul 22, 2020
- Review
- 84 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K171593 (2017). 8 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK171593 InMode RF SystemInmode MD, Ltd. · 2017
- 1 generation backK182325 InMode RF SystemInmode MD, Ltd. · 2018
- This deviceK201150 InMode RF Multi-SystemInMode, Ltd. · 2020
- Descendant · cites it directly · 7 of its ownK210492 InMode RF Pro SystemInmode MD, Ltd. · 2021
- Descendant · 2 generations on · 2 of its ownK221571 InMode Multi-systemInMode, Ltd. · 2022
- Descendant · 3 generations on · 1 of its ownK251632 Optimas MAX SystemInMode, Ltd. · 2025
- Descendant · 2 generations on · 1 of its ownK212253 Apollo Duet (Model : APD-4000)Weero Co. · 2022
- Descendant · 3 generations on · 0 of its ownK253261 Apollo Quattro (APQ-10M)Weero Co., Ltd. · 2026
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K210492InMode RF Pro SystemInmode MD, Ltd. · 2021 · cites it directly7descendants
- K221571InMode Multi-systemInMode, Ltd. · 2022 · 2 generations on2descendants
- K251632Optimas MAX SystemInMode, Ltd. · 2025 · 3 generations on1descendant
- K212253Apollo Duet (Model : APD-4000)Weero Co. · 2022 · 2 generations on1descendant
- K253261Apollo Quattro (APQ-10M)Weero Co., Ltd. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K171593 | InMode RF System | Inmode MD, Ltd. | 2017 | — |
| −1 | K182325 | InMode RF System | Inmode MD, Ltd. | 2018 | — |
| 0 (this device) | K201150 | InMode RF Multi-System | InMode, Ltd. | 2020 | — |
| +1 | K210492 | InMode RF Pro System | Inmode MD, Ltd. | 2021 | — |
| +2 | K221571 | InMode Multi-system | InMode, Ltd. | 2022 | — |
| +3 | K251632 | Optimas MAX System | InMode, Ltd. | 2025 | — |
| +2 | K212253 | Apollo Duet (Model : APD-4000) | Weero Co. | 2022 | — |
| +3 | K253261 | Apollo Quattro (APQ-10M) | Weero Co., Ltd. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 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 GEI? 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 GEI device
- #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 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 |
|---|---|---|---|
| * | K182325 | InMode RF SystemSummary page 5…510(k) No. Main Predicate InMode Ltd. InMode RF System K182325 Reference Predicates InMode Ltd. InMode System MiniFX Applicator… | 2018 |
| † | K160329 | InMode System MiniFX Handpiece | 2016 |
| † | K131362 | Inmode Wmbody Device | 2013 |
| † | K172302 | InMode PLUS System | 2017 |
| † | K140926 | Inmode Wmface Device | 2014 |
| † | K102461 | Fractora | 2011 |
| † | K180189 | InMode System with Fractora3D/3D-90 Applicators | 2018 |
| † | K151273 | InMode FRF Applicator | 2016 |
| † | K192695 | InMode System with the Morpheus8 (Fractora) Applicators | 2019 |
| † | K200947 | InMode System with the Morhpeus8 Applicators | 2020 |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K210492 | InMode RF Pro System | 2021 | 7 |
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 3 years and passes through 2 companies; a new generation was cleared every 1.8 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K210492 (Inmode MD, Ltd., 2021) has gone furthest, with 7 descendants of its own.
- 1 other device also cites its predicate K182325.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · GEI
52in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEI
113in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEI
4in 2025
Class I (14 since 2007) Class II/III not classified
Adverse event reports per year · GEI
7,592in 2025
MAUDE reports naming product code GEI, 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 | 50 | 51 | 21 | 2,795 |
| 2008 | 61 | 71 | 19 | 2,556 |
| 2009 | 42 | 130 | 27 | 3,591 |
| 2010 | 46 | 109 | 51 | 3,377 |
| 2011 | 35 | 135 | 32 | 4,463 |
| 2012 | 39 | 133 | 30 | 5,216 |
| 2013 | 48 | 136 | 13 | 4,897 |
| 2014 | 49 | 103 | 3 | 4,908 |
| 2015 | 47 | 123 | 4 | 4,936 |
| 2016 | 64 | 108 | 3 | 5,616 |
| 2017 | 52 | 72 | 2 | 6,073 |
| 2018 | 47 | 93 | 6 | 6,545 |
| 2019 | 48 | 93 | 5 | 7,067 |
| 2020 | 59 | 105 | 1 | 6,490 |
| 2021 | 46 | 146 | 6 | 6,354 |
| 2022 | 55 | 150 | 49 | 6,103 |
| 2023 | 65 | 104 | 27 (4) | 7,176 |
| 2024 | 59 | 125 | 22 (10) | 7,897 |
| 2025 | 52 | 113 | 4 | 7,592 |
| 2026 | 43 | 183 | 8 | — |
What is it indicated for?
The InMode RF Multi-System with the Non-invasive Applicators employs RF energy for various applications: *Forma (Plus), Plus (Plus Plus) and Plus90 for relief of minor muscle aches and pain, relief of muscle spasm, and temporary improvement of local blood circulation. *WMface is intended for use in dermatologic procedures for non-invasive treatment of mild to moderate facial wrinkles and rhytids. *BodyFX™ (WMBody)/MiniFX™ for Relief of minor muscle aches…
Read the full statement (186 words)
The InMode RF Multi-System with the Non-invasive Applicators employs RF energy for various applications:
*Forma (Plus), Plus (Plus Plus) and Plus90 for relief of minor muscle aches and pain, relief of muscle spasm, and temporary improvement of local blood circulation.
*WMface is intended for use in dermatologic procedures for non-invasive treatment of mild to moderate facial wrinkles and rhytids.
*BodyFX™ (WMBody)/MiniFX™ for Relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation and temporary reduction in the appearance of cellulite.
The InMode RF Multi-System with the Fractional Applicators employs RF energy for various applications:
*Fractora Applicator with 60 pins tip is designed for use in dermatological procedures requiring ablation and resurfacing of the skin.
*Fractora Applicator with 24 pins tip is intended for use in dermatological and general surgical procedures for electrocoagulation and hemostasis.
At higher energy levels greater than 62mJ/pin, use of the applicator is limited to skin types I-IV
*Morpheus8™ for dermatological and general surgical procedures for electrocoagulation and hemostasis.
At higher energy levels greater than 62mJ/pin, use of the applicator is limited to skin types I-IV
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/K201150 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201150: InMode RF Multi-System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201150
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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