510(k) · Cleared
ClearedInMode RF System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inmode MD, Ltd. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Sep 26, 2018 as substantially equivalent to K171593 (Inmode MD, Ltd., 2017) after a 30-day review. Its family tree reaches back 1 generation to 2017. 14 later devices descend from it.
- Decided
- Sep 26, 2018
- Review
- 30 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K171593 (2017). 14 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK171593 InMode RF SystemInmode MD, Ltd. · 2017
- This deviceK182325 InMode RF SystemInmode MD, Ltd. · 2018
- Descendant · cites it directly · 8 of its ownK201150 InMode RF Multi-SystemInMode, Ltd. · 2020
- Descendant · 2 generations on · 7 of its ownK210492 InMode RF Pro SystemInmode MD, Ltd. · 2021
- Descendant · cites it directly · 4 of its ownK233642 InMode RF SystemInMode, Ltd. · 2024
- Descendant · 2 generations on · 3 of its ownK240780 InMode RF SystemInMode, Ltd. · 2024
- Descendant · 3 generations on · 2 of its ownK221571 InMode Multi-systemInMode, Ltd. · 2022
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K201150InMode RF Multi-SystemInMode, Ltd. · 2020 · cites it directly8descendants
- K210492InMode RF Pro SystemInmode MD, Ltd. · 2021 · 2 generations on7descendants
- K233642InMode RF SystemInMode, Ltd. · 2024 · cites it directly4descendants
- K240780InMode RF SystemInMode, Ltd. · 2024 · 2 generations on3descendants
- K221571InMode Multi-systemInMode, Ltd. · 2022 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K171593 | InMode RF System | Inmode MD, Ltd. | 2017 | — |
| 0 (this device) | K182325 | InMode RF System | Inmode MD, Ltd. | 2018 | — |
| +1 | K201150 | InMode RF Multi-System | InMode, Ltd. | 2020 | — |
| +2 | K210492 | InMode RF Pro System | Inmode MD, Ltd. | 2021 | — |
| +1 | K233642 | InMode RF System | InMode, Ltd. | 2024 | — |
| +2 | K240780 | InMode RF System | InMode, Ltd. | 2024 | — |
| +3 | K221571 | InMode Multi-system | InMode, Ltd. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2024 | 3 | 0 |
| 2025 | 4 | 0 |
| 2026 | 3 | 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 |
|---|---|---|---|
| * | K171593 | InMode RF SystemSummary page 4…by InMode MD Ltd. Device Manufacturer 510(k) No. InMode RF System InMode MD Ltd. K171593 21… | 2017 |
What descends from it? (14)
See all 142 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?
- Its one ancestor has no recall.
- Of its descendants, K201150 (InMode, Ltd., 2020) has gone furthest, with 8 descendants of its own.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 System is indicated for use in dermatological and general surgical procedures for electro-coagulation and hemostasis
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/K182325 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182325: InMode RF System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182325
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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