510(k) · Cleared
ClearedInMode RF Pro 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 Jul 12, 2021 as substantially equivalent to K201150 (InMode, Ltd., 2020) after a 143-day review. Its family tree reaches back 3 generations to 2017. 7 later devices descend from it.
- Decided
- Jul 12, 2021
- Review
- 143 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K171593 (2017). 7 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK171593 InMode RF SystemInmode MD, Ltd. · 2017
- 2 generations backK182325 InMode RF SystemInmode MD, Ltd. · 2018
- 1 generation backK201150 InMode RF Multi-SystemInMode, Ltd. · 2020
- This deviceK210492 InMode RF Pro SystemInmode MD, Ltd. · 2021
- Descendant · cites it directly · 2 of its ownK221571 InMode Multi-systemInMode, Ltd. · 2022
- Descendant · 2 generations on · 1 of its ownK251632 Optimas MAX SystemInMode, Ltd. · 2025
- Descendant · cites it directly · 1 of its ownK212253 Apollo Duet (Model : APD-4000)Weero Co. · 2022
- Descendant · 2 generations on · 0 of its ownK253261 Apollo Quattro (APQ-10M)Weero Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK252367 InbellaMulti SystemInbella Medical, Inc. · 2025
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K221571InMode Multi-systemInMode, Ltd. · 2022 · cites it directly2descendants
- K251632Optimas MAX SystemInMode, Ltd. · 2025 · 2 generations on1descendant
- K212253Apollo Duet (Model : APD-4000)Weero Co. · 2022 · cites it directly1descendant
- K253261Apollo Quattro (APQ-10M)Weero Co., Ltd. · 2026 · 2 generations on0descendants
- K252367InbellaMulti SystemInbella Medical, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K171593 | InMode RF System | Inmode MD, Ltd. | 2017 | — |
| −2 | K182325 | InMode RF System | Inmode MD, Ltd. | 2018 | — |
| −1 | K201150 | InMode RF Multi-System | InMode, Ltd. | 2020 | — |
| 0 (this device) | K210492 | InMode RF Pro System | Inmode MD, Ltd. | 2021 | — |
| +1 | K221571 | InMode Multi-system | InMode, Ltd. | 2022 | — |
| +2 | K251632 | Optimas MAX System | InMode, Ltd. | 2025 | — |
| +1 | K212253 | Apollo Duet (Model : APD-4000) | Weero Co. | 2022 | — |
| +2 | K253261 | Apollo Quattro (APQ-10M) | Weero Co., Ltd. | 2026 | — |
| +1 | K252367 | InbellaMulti System | Inbella Medical, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K201150 | InMode RF Multi-SystemSummary page 5…devices; Manufacturer Device 510(k) No. InMode Ltd. InMode RF Multi System K201150 Device Description: The InMode RF Pro System supports multiple radiofrequency (RF) applications and accessories. The InMode RF P… | 2020 |
What descends from it? (7)
4 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 4 years and passes through 2 companies; a new generation was cleared every 12 months on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K221571 (InMode, Ltd., 2022) has gone furthest, with 2 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. 2021, 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 Pro System with the Non-invasive Applicators employs RF energy for various applications: • i-Forma, 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…
Read the full statement (195 words)
The InMode RF Pro System with the Non-invasive Applicators employs RF energy for various applications:
• i-Forma, 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 Pro 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 as stated in the FDA summary.
https://510kreport.com/device/K210492 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210492: InMode RF Pro System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210492
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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