510(k) · Cleared
ClearedInMode Multi-system
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
InMode, Ltd. · GEX Powered Laser Surgical Instrument
Cleared on Jun 30, 2022 as substantially equivalent to K180719 (Inmode MD, Ltd., 2018) and 11 other predicates after a 30-day review. Its family tree reaches back 23 generations to 1995. 2 later devices descend from it.
- Decided
- Jun 30, 2022
- Review
- 30 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 12
Its longest line of descent runs back 23 generations to K943450 (1995). 643 ancestors in all, the oldest K771218 (1978). 2 later devices descend from it, 1 citing it directly.
- Root · 23 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 19 generations between
- 3 generations backK152012 EVO platformQuanta System Spa · 2015
- 2 generations backK160368 EVO platformQuanta System Spa · 2016
- 1 generation backK173677 InMode VLazeInmode MD, Ltd. · 2018
- This deviceK221571 InMode Multi-systemInMode, Ltd. · 2022
- Descendant · cites it directly · 1 of its ownK251632 Optimas MAX SystemInMode, Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK252215 InbellaMAX SystemInbella Medical, Ltd. · 2025
Show all 23 generations
- Root · 23 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 22 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 21 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 20 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 19 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 18 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 17 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 16 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 15 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 14 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 13 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 12 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 11 generations backK051214 Aluma Skin Renewal SystemLumenis, Inc. · 2005
- 10 generations backK060448 Lumenis One Family of Systems; Lumenis One.Lumenis, Ltd. · 2006
- 9 generations backK072564 Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008
- 8 generations backK083899 Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc. · 2009
- 7 generations backK103118 Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc. · 2010 · Recalled
- 6 generations backK121346 Picosure WorkstationCynosure, Inc. · 2012
- 5 generations backK142372 Pico Way Laser SystemCandela Corpation · 2014
- 4 generations backK150326 PicoWay Laser SystemCandela Corporation · 2015
- 3 generations backK152012 EVO platformQuanta System Spa · 2015
- 2 generations backK160368 EVO platformQuanta System Spa · 2016
- 1 generation backK173677 InMode VLazeInmode MD, Ltd. · 2018
- This deviceK221571 InMode Multi-systemInMode, Ltd. · 2022
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −23 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −22 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −21 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −20 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −19 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −18 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −17 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −16 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −15 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −14 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −13 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −12 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −11 | K051214 | Aluma Skin Renewal System | Lumenis, Inc. | 2005 | — |
| −10 | K060448 | Lumenis One Family of Systems; Lumenis One. | Lumenis, Ltd. | 2006 | — |
| −9 | K072564 | Alma Lasers Harmony XL Multi-Application Platform | Alma Lasers, Ltd. | 2008 | — |
| −8 | K083899 | Revlite Q-Switched ND:Yag Laser System | Hoya Conbio, Inc. | 2009 | — |
| −7 | K103118 | Revlite Q-Switched ND: Yag Laser System with Nadpiece Adaptor | Hoya Photonics, Inc. | 2010 | 1 |
| −6 | K121346 | Picosure Workstation | Cynosure, Inc. | 2012 | — |
| −5 | K142372 | Pico Way Laser System | Candela Corpation | 2014 | — |
| −4 | K150326 | PicoWay Laser System | Candela Corporation | 2015 | — |
| −3 | K152012 | EVO platform | Quanta System Spa | 2015 | — |
| −2 | K160368 | EVO platform | Quanta System Spa | 2016 | — |
| −1 | K173677 | InMode VLaze | Inmode MD, Ltd. | 2018 | — |
| 0 (this device) | K221571 | InMode Multi-system | InMode, Ltd. | 2022 | — |
| +1 | K251632 | Optimas MAX System | InMode, Ltd. | 2025 | — |
| +2 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 2 | 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 GEX? 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 GEX device
- #1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (12)
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 |
|---|---|---|---|
| * | K180719 | InMode Diolaze SystemSummary page 5…device 510(K) number Main platform/ 878.4810 GEX Primary K180719 Console Diolaze XL 878.4810 GEX Secondary K180719 VLaze 878.4810 GE… | 2018 |
| * | K173677 | InMode VLazeSummary page 5…K180719 Console Diolaze XL 878.4810 GEX Secondary K180719 VLaze 878.4810 GEX Secondary K173677 SR IPL 878.4810 ONF Secondary K123860 Fractional RF 878.4810 GEI… | 2018 |
| * | K123860 | Inmode SR Ipl DeviceSummary page 5…K180719 VLaze 878.4810 GEX Secondary K173677 SR IPL 878.4810 ONF Secondary K123860 Fractional RF 878.4810 GEI Secondary K200947, Applicators:… | 2013 |
| * | K200947 | InMode System with the Morhpeus8 ApplicatorsSummary page 5…K173677 SR IPL 878.4810 ONF Secondary K123860 Fractional RF 878.4810 GEI Secondary K200947, Applicators: K180189, FRACTORA 60… | 2020 |
| * | K180189 | InMode System with Fractora3D/3D-90 ApplicatorsSummary page 5…K123860 Fractional RF 878.4810 GEI Secondary K200947, Applicators: K180189, FRACTORA 60 K151273, Pin, InMode FRF… | 2018 |
| * | K151273 | InMode FRF ApplicatorSummary page 5…K200947, Applicators: K180189, FRACTORA 60 K151273, Pin, InMode FRF K102461 24 Pin, Morpheus8, FRACTORA 3D Applicators… | 2016 |
| * | K102461 | FractoraSummary page 5…K180189, FRACTORA 60 K151273, Pin, InMode FRF K102461 24 Pin, Morpheus8, FRACTORA 3D Applicators BodyFX 878.4810 NUV, Secondary K131362 (… | 2011 |
| * | K131362 | Inmode Wmbody DeviceSummary page 5…K102461 24 Pin, Morpheus8, FRACTORA 3D Applicators BodyFX 878.4810 NUV, Secondary K131362 (WMBody) 890.5560 ISA Applicator MiniFX 878.4400 GEI, Secondary K16… | 2013 |
| * | K160329 | InMode System MiniFX HandpieceSummary page 5…NUV, Secondary K131362 (WMBody) 890.5560 ISA Applicator MiniFX 878.4400 GEI, Secondary K160329 Applicator 890.5560 ISA Forma (Plus), 878.4400 PBX, Secondary K172302 Plus90… | 2016 |
| * | K172302 | InMode PLUS SystemSummary page 5…78.4400 GEI, Secondary K160329 Applicator 890.5560 ISA Forma (Plus), 878.4400 PBX, Secondary K172302 Plus90 and Plus 890.5560 ISA (Plus-Plus) Applicators i-Forma 878.4400 PBX, Secondary… | 2017 |
| * | K210492 | InMode RF Pro SystemSummary page 5…Secondary K172302 Plus90 and Plus 890.5560 ISA (Plus-Plus) Applicators i-Forma 878.4400 PBX, Secondary K210492 Applicator 890.5560 ISA WMFace 878.4400 GEI, Secondary K140926 Applic… | 2021 |
| * | K140926 | Inmode Wmface DeviceSummary page 5…78.4400 PBX, Secondary K210492 Applicator 890.5560 ISA WMFace 878.4400 GEI, Secondary K140926 Applicator 50 InMode Multi System 510(k) file… | 2014 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K251632 | Optimas MAX System | 2025 | 1 |
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 27 years and passes through 14 companies; a new generation was cleared every 10 months on median.
- 32 of the 643 ancestors have a recall of any class.
- Of its descendants, K251632 (InMode, Ltd., 2025) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K180719.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · GEX
83in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEX
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEX
3in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GEX
2,720in 2025
MAUDE reports naming product code GEX, 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 | 73 | 79 | 9 | 342 |
| 2008 | 107 | 86 | 2 | 232 |
| 2009 | 69 | 100 | 0 | 209 |
| 2010 | 50 | 96 | 4 | 1,711 |
| 2011 | 41 | 83 | 18 | 3,024 |
| 2012 | 45 | 118 | 5 | 2,000 |
| 2013 | 46 | 144 | 3 | 2,236 |
| 2014 | 61 | 147 | 6 | 2,036 |
| 2015 | 47 | 112 | 0 | 2,099 |
| 2016 | 51 | 114 | 1 | 2,585 |
| 2017 | 67 | 90 | 5 (1) | 2,977 |
| 2018 | 51 | 78 | 5 | 3,525 |
| 2019 | 41 | 88 | 6 | 2,709 |
| 2020 | 52 | 90 | 1 | 2,183 |
| 2021 | 53 | 123 | 0 | 3,465 |
| 2022 | 60 | 152 | 0 | 2,288 |
| 2023 | 52 | 87 | 6 | 2,337 |
| 2024 | 82 | 90 | 3 | 2,187 |
| 2025 | 83 | 90 | 0 | 2,720 |
| 2026 | 57 | 90 | 2 | — |
What is it indicated for?
The InMode Multi System with the Diode laser Applicators is indicated for: Diolaze XL. 810nm Applicator 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. Diolaze XL 755/810nm & 810/1064nm Applicators are intended for hair removal. VLaze Applicator is intended for the treatment of vascular lesions, including angiomas, hemangiomas…
Read the full statement (333 words)
The InMode Multi System with the Diode laser Applicators is indicated for:
Diolaze XL. 810nm Applicator 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.
Diolaze XL 755/810nm & 810/1064nm Applicators are intended for hair removal.
VLaze Applicator is intended for the treatment of vascular lesions, including angiomas, hemangiomas, telangiectasia, port wine stains, leg veins and other benign vascular lesions.
The InMode Multi System with the IPL. Applicator is indicated for:
[PL Applicator with wavelengths (515-1200nm) is 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, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikilodenna of Civatte, superficial leg veins and venlous malformations.
The InMode Multi System with the non-invasive RF Applicators is indicated for:
BodyFX (WMBody) and MiniFX Applicators are intended for the treatment of the following medical conditions: Relief of minor muscle aches and pains, relief of muscle spasm, temporary improvement of local blood circulation; and temporary reduction in the appearance of cellulite.
PLUS/ PLUS90/PLUS-PLUS (FORMA) and i-Forma Applicators are indicated for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasm, and temporary improvement of local blood circulation.
FaceFX (WMFace) Applicator is intended for use in dermatologic procedures, for noninvasive treatment of mild to moderate facial wrinkles and rhytids.
The InMode Multi System with the Fractional RF Applicators is indicated for:
FRACTORA 60 pin Applicator is intended for use in dermatological procedures requiring ablation and resurfacing of the skin.
FRF 24 pin Applicator is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.
Fractora3D and Morpheus8 Applicators are intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. At higher energy levels greater than 62 mJ/pin, use 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/K221571 · printed Nov 4, 2026
Cite this page
510(k) Report. “K221571: InMode Multi-system.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K221571
Report an extraction error
Are you the manufacturer?
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