510(k) · Cleared
ClearedInbellaMulti System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inbella Medical, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Oct 15, 2025 as substantially equivalent to K210492 (Inmode MD, Ltd., 2021) and 1 other predicate after a 77-day review. Its family tree reaches back 22 generations to 1995.
- Decided
- Oct 15, 2025
- Review
- 77 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 22 generations to K943450 (1995). 265 ancestors in all, the oldest K800617 (1980). No later device cites it as a predicate yet.
- Root · 22 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 18 generations between
- 3 generations backK192695 InMode System with the Morpheus8 (Fractora) ApplicatorsInmode MD, Ltd. · 2019
- 2 generations backK200947 InMode System with the Morhpeus8 ApplicatorsInMode, Ltd. · 2020
- 1 generation backK231790 The InMode System with the Morpheus8 ApplicatorsInMode, Ltd. · 2023
- This deviceK252367 InbellaMulti SystemInbella Medical, Inc. · 2025
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 backK032088 Modification to Thermacool TC SystemThermage, Inc. · 2003
- 11 generations backK052778 Thermage Thermacool Skin MarketingThermage, Inc. · 2005
- 10 generations backK060948 Portrait PSR3Rhytec Incorporated · 2006 · Recalled
- 9 generations backK071786 Portrait PSRRhytec Incorporated · 2007
- 8 generations backK072394 Portrait Stand-OffRhytec Incorporated · 2007
- 7 generations backK073572 Matrix RF ApplicatorSyneron Medical, Ltd. · 2008
- 6 generations backK101510 Fractional Skin Resurfacing (FSR) ApplicatorEndymed Medical, Ltd. · 2011
- 5 generations backK130501 IntensifEndymed Medical, Ltd. · 2014
- 4 generations backK180189 InMode System with Fractora3D/3D-90 ApplicatorsInmode MD, Ltd. · 2018
- 3 generations backK192695 InMode System with the Morpheus8 (Fractora) ApplicatorsInmode MD, Ltd. · 2019
- 2 generations backK200947 InMode System with the Morhpeus8 ApplicatorsInMode, Ltd. · 2020
- 1 generation backK231790 The InMode System with the Morpheus8 ApplicatorsInMode, Ltd. · 2023
- This deviceK252367 InbellaMulti SystemInbella Medical, Inc. · 2025
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 | K032088 | Modification to Thermacool TC System | Thermage, Inc. | 2003 | — |
| −11 | K052778 | Thermage Thermacool Skin Marketing | Thermage, Inc. | 2005 | — |
| −10 | K060948 | Portrait PSR3 | Rhytec Incorporated | 2006 | 1 |
| −9 | K071786 | Portrait PSR | Rhytec Incorporated | 2007 | — |
| −8 | K072394 | Portrait Stand-Off | Rhytec Incorporated | 2007 | — |
| −7 | K073572 | Matrix RF Applicator | Syneron Medical, Ltd. | 2008 | — |
| −6 | K101510 | Fractional Skin Resurfacing (FSR) Applicator | Endymed Medical, Ltd. | 2011 | — |
| −5 | K130501 | Intensif | Endymed Medical, Ltd. | 2014 | — |
| −4 | K180189 | InMode System with Fractora3D/3D-90 Applicators | Inmode MD, Ltd. | 2018 | — |
| −3 | K192695 | InMode System with the Morpheus8 (Fractora) Applicators | Inmode MD, Ltd. | 2019 | — |
| −2 | K200947 | InMode System with the Morhpeus8 Applicators | InMode, Ltd. | 2020 | — |
| −1 | K231790 | The InMode System with the Morpheus8 Applicators | InMode, Ltd. | 2023 | — |
| 0 (this device) | K252367 | InbellaMulti System | Inbella Medical, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1982 | 2 | 0 |
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 5 | 0 |
| 1992 | 3 | 0 |
| 1993 | 8 | 0 |
| 1994 | 15 | 0 |
| 1995 | 14 | 0 |
| 1996 | 20 | 0 |
| 1997 | 22 | 0 |
| 1998 | 14 | 0 |
| 1999 | 11 | 0 |
| 2000 | 21 | 0 |
| 2001 | 23 | 0 |
| 2002 | 28 | 0 |
| 2003 | 23 | 0 |
| 2004 | 10 | 0 |
| 2005 | 5 | 0 |
| 2006 | 1 | 0 |
| 2007 | 4 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 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? (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 |
|---|---|---|---|
| * | K210492 | InMode RF Pro SystemSummary page 5…laMulti System manufactured by Inbella Medical, Inc. (platform and all applicators other than BellaM8) is substantially equivalent to the InMode RF Pro System cleared in K210492 by InMode Ltd. For the BellaM8 applicator, the subject device is substantially equivalent to the InMode System with Morpheus8 app… | 2021 |
| * | K231790 | The InMode System with the Morpheus8 ApplicatorsSummary page 5…m cleared in K210492 by InMode Ltd. For the BellaM8 applicator, the subject device is substantially equivalent to the InMode System with Morpheus8 applicators cleared in K231790 by InMode Ltd. Purpose of the 510(k) Notice: The InBellaMulti System manufactured by Inbella Medical, Inc. is identical in all… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
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 30 years and passes through 8 companies; a new generation was cleared every 1.0 years on median.
- 10 of the 265 ancestors have a recall of any class.
- 3 other devices also cite its predicate K210492.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 InbellaMulti System with the Non-invasive Applicators employs RF energy for various applications: * i-BellaForma, BellaForma, BellaPlus and BellaPlus90 for relief of minor muscle aches and pain, relief of muscle spasm, and temporary improvement of local blood circulation. *BellaWMface is intended for use in dermatologic procedures for non-invasive treatment of mild to moderate facial wrinkles and rhytids. * BellaBodyF X /BellaMiniFX for Relief of…
Read the full statement (190 words)
The InbellaMulti System with the Non-invasive Applicators employs RF energy for various applications:
* i-BellaForma, BellaForma, BellaPlus and BellaPlus90 for relief of minor muscle aches and pain, relief of muscle spasm, and temporary improvement of local blood circulation.
*BellaWMface is intended for use in dermatologic procedures for non-invasive treatment of mild to moderate facial wrinkles and rhytids.
* BellaBodyF X /BellaMiniFX 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 InbellaMulti System with the Fractional Applicators employs RF energy for various applications:
* BellaFractora Applicator with 60 pins tip is designed for use in dermatological procedures requiring ablation and resurfacing of the skin.
* BellaFractora 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-1V
* BellaM8 for dermatologic procedures where coagulation/contraction of soft tissue or hemostasis is needed. 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/K252367 · printed Nov 5, 2026
Cite this page
510(k) Report. “K252367: InbellaMulti System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K252367
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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