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 Oct 10, 2017 after a 132-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 15 later devices descend from it.
- Decided
- Oct 10, 2017
- Review
- 132 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
15 later devices descend from it, 1 citing it directly.
- This deviceK171593 InMode RF SystemInmode MD, Ltd. · 2017
- Descendant · cites it directly · 14 of its ownK182325 InMode RF SystemInmode MD, Ltd. · 2018
- Descendant · 2 generations on · 8 of its ownK201150 InMode RF Multi-SystemInMode, Ltd. · 2020
- Descendant · 3 generations on · 7 of its ownK210492 InMode RF Pro SystemInmode MD, Ltd. · 2021
- Descendant · 2 generations on · 4 of its ownK233642 InMode RF SystemInMode, Ltd. · 2024
- Descendant · 3 generations on · 3 of its ownK240780 InMode RF SystemInMode, Ltd. · 2024
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K182325InMode RF SystemInmode MD, Ltd. · 2018 · cites it directly14descendants
- K201150InMode RF Multi-SystemInMode, Ltd. · 2020 · 2 generations on8descendants
- K210492InMode RF Pro SystemInmode MD, Ltd. · 2021 · 3 generations on7descendants
- K233642InMode RF SystemInMode, Ltd. · 2024 · 2 generations on4descendants
- K240780InMode RF SystemInMode, Ltd. · 2024 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K171593 | InMode RF System | Inmode MD, Ltd. | 2017 | — |
| +1 | K182325 | InMode RF System | Inmode MD, Ltd. | 2018 | — |
| +2 | K201150 | InMode RF Multi-System | InMode, Ltd. | 2020 | — |
| +3 | K210492 | InMode RF Pro System | Inmode MD, Ltd. | 2021 | — |
| +2 | K233642 | InMode RF System | InMode, Ltd. | 2024 | — |
| +3 | K240780 | InMode RF System | InMode, Ltd. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K160193 | InMode RF System Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 4…red by InMode MD Ltd. Device Manufacturer 510(k) No. InMode RF System InMode MD Ltd. K160193 Page 6-1… |
What descends from it? (15)
See all 151 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K182325 | InMode RF System | 2018 | 14 |
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?
- Of its descendants, K182325 (Inmode MD, Ltd., 2018) has gone furthest, with 14 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. 2017, 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/K171593 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171593: 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/K171593
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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