510(k) · Cleared
ClearedInbellaMAX System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inbella Medical, Ltd. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Jul 25, 2025 as substantially equivalent to K251632 (InMode, Ltd., 2025) after a 10-day review. Its family tree reaches back 25 generations to 1995.
- Decided
- Jul 25, 2025
- Review
- 10 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 25 generations to K943450 (1995). 646 ancestors in all, the oldest K771218 (1978). No later device cites it as a predicate yet.
- Root · 25 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 21 generations between
- 3 generations backK173677 InMode VLazeInmode MD, Ltd. · 2018
- 2 generations backK221571 InMode Multi-systemInMode, Ltd. · 2022
- 1 generation backK251632 Optimas MAX SystemInMode, Ltd. · 2025
- This deviceK252215 InbellaMAX SystemInbella Medical, Ltd. · 2025
Show all 25 generations
- Root · 25 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 24 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 23 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 22 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 21 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 20 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 19 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 18 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 17 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 16 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 15 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 14 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 13 generations backK051214 Aluma Skin Renewal SystemLumenis, Inc. · 2005
- 12 generations backK060448 Lumenis One Family of Systems; Lumenis One.Lumenis, Ltd. · 2006
- 11 generations backK072564 Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008
- 10 generations backK083899 Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc. · 2009
- 9 generations backK103118 Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc. · 2010 · Recalled
- 8 generations backK121346 Picosure WorkstationCynosure, Inc. · 2012
- 7 generations backK142372 Pico Way Laser SystemCandela Corpation · 2014
- 6 generations backK150326 PicoWay Laser SystemCandela Corporation · 2015
- 5 generations backK152012 EVO platformQuanta System Spa · 2015
- 4 generations backK160368 EVO platformQuanta System Spa · 2016
- 3 generations backK173677 InMode VLazeInmode MD, Ltd. · 2018
- 2 generations backK221571 InMode Multi-systemInMode, Ltd. · 2022
- 1 generation backK251632 Optimas MAX SystemInMode, Ltd. · 2025
- This deviceK252215 InbellaMAX SystemInbella Medical, Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −25 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −24 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −23 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −22 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −21 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −20 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −19 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −18 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −17 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −16 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −15 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −14 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −13 | K051214 | Aluma Skin Renewal System | Lumenis, Inc. | 2005 | — |
| −12 | K060448 | Lumenis One Family of Systems; Lumenis One. | Lumenis, Ltd. | 2006 | — |
| −11 | K072564 | Alma Lasers Harmony XL Multi-Application Platform | Alma Lasers, Ltd. | 2008 | — |
| −10 | K083899 | Revlite Q-Switched ND:Yag Laser System | Hoya Conbio, Inc. | 2009 | — |
| −9 | K103118 | Revlite Q-Switched ND: Yag Laser System with Nadpiece Adaptor | Hoya Photonics, Inc. | 2010 | 1 |
| −8 | K121346 | Picosure Workstation | Cynosure, Inc. | 2012 | — |
| −7 | K142372 | Pico Way Laser System | Candela Corpation | 2014 | — |
| −6 | K150326 | PicoWay Laser System | Candela Corporation | 2015 | — |
| −5 | K152012 | EVO platform | Quanta System Spa | 2015 | — |
| −4 | K160368 | EVO platform | Quanta System Spa | 2016 | — |
| −3 | K173677 | InMode VLaze | Inmode MD, Ltd. | 2018 | — |
| −2 | K221571 | InMode Multi-system | InMode, Ltd. | 2022 | — |
| −1 | K251632 | Optimas MAX System | InMode, Ltd. | 2025 | — |
| 0 (this device) | K252215 | InbellaMAX System | Inbella Medical, Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1980 | 1 | 0 |
| 1981 | 1 | 0 |
| 1982 | 2 | 0 |
| 1984 | 1 | 0 |
| 1985 | 2 | 0 |
| 1986 | 3 | 0 |
| 1987 | 2 | 0 |
| 1988 | 4 | 0 |
| 1989 | 5 | 0 |
| 1990 | 7 | 0 |
| 1991 | 12 | 0 |
| 1992 | 6 | 0 |
| 1993 | 12 | 0 |
| 1994 | 28 | 0 |
| 1995 | 28 | 0 |
| 1996 | 30 | 0 |
| 1997 | 33 | 0 |
| 1998 | 35 | 0 |
| 1999 | 30 | 0 |
| 2000 | 37 | 0 |
| 2001 | 36 | 0 |
| 2002 | 46 | 0 |
| 2003 | 50 | 0 |
| 2004 | 40 | 0 |
| 2005 | 34 | 0 |
| 2006 | 22 | 0 |
| 2007 | 27 | 0 |
| 2008 | 23 | 0 |
| 2009 | 14 | 0 |
| 2010 | 6 | 0 |
| 2011 | 10 | 0 |
| 2012 | 4 | 0 |
| 2013 | 3 | 0 |
| 2014 | 8 | 0 |
| 2015 | 4 | 0 |
| 2016 | 3 | 0 |
| 2017 | 3 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K251632 | Optimas MAX SystemSummary page 5…: GEX, GEI, ONF, PBX Predicate Device: The InbellaMAX System manufactured by Inbella Medical is substantially equivalent to the Optimas MAX System cleared in K251632 by InMode Ltd. Purpose of the 510(k) notice: The device manufactured by Inbella Medical is identical in all aspects to the list… | 2025 |
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 15 companies; a new generation was cleared every 10 months on median.
- 32 of the 646 ancestors have a recall of any class.
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 InbellaMAX System with the BellaXL 810 Black is intended for hair removal and permanent hair reduction defined as the stable, long-term reduction in hair counts at 6, 9, or 12 months following a treatment regime. The BellaXL 755/810 Black and the BellaXL 810/1064 Black are intended for hair removal. The InbellaMAX System with the BellaVlaze Black is intended for the treatment of vascular lesions, including angiomas, hemangiomas, telangiectasia, port…
Read the full statement (220 words)
The InbellaMAX System with the BellaXL 810 Black is intended for hair removal and permanent hair reduction defined
as the stable, long-term reduction in hair counts at 6, 9, or 12 months following a treatment regime. The BellaXL 755/810
Black and the BellaXL 810/1064 Black are intended for hair removal.
The InbellaMAX System with the BellaVlaze Black is intended for the treatment of vascular lesions, including angiomas,
hemangiomas, telangiectasia, port wine stains, leg veins and other benign vascular lesions.
The InbellaMAX System with the Bella515 and Bella580 Black Applicators are indicated for use for the following
treatments:
• The treatment of benign pigmented epidermal lesions, including dyschromia, hyperpigmentation, melasma, ephelides
(freckles);
• The treatment of benign cutaneous vascular lesions, including port wine stains, facial, truncaland leg telangiectasias,
rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, superficial leg veins and venous
malformations.
The InbellaMAX System with the BellaPlus and BellaForma Handpieces are indicated for the temporary relief of minor
muscle aches and pain, temporary relief of muscle spasm, and temporary improvement of local blood circulation.
The InbellaMAX System with the BellaM8 BApplicators is intended for use in dermatologic procedures where
coagulation/contraction of soft tissue or hemostasis is needed. At higher energy levels greater than 62 mJ/pin, the use of
the Morpheus8 Applicator is limited to Skin Types I-IV.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252215 · printed Nov 5, 2026
Cite this page
510(k) Report. “K252215: InbellaMAX System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K252215
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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