Data / Medical devices / Israel / Inmode Ltd.
Inmode Ltd.: FDA-registered device maker in Yokneam Northern, Israel, 36 510(k) clearances
Inmode Ltd. is registered with the FDA (registration 3010511300) in Yokneam Northern, Israel. It lists 10 device types. The FDA files 36 510(k) clearances under its listings, the newest dated January 15, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010511300
- Address
- Tavor Building (POB 533) Shaar Yokneam, Yokneam Northern, Israel, 2069206
- Owner or operator
- INMODE LTD. (10045478)
- Roles
- Manufacturer
- First device listed
- November 21, 2013
- Registered through
- 2026
- Brand names listed
- AG613051A, AG613052A, AG613053A, AG613054A, AG613055A, AG613056A, APEX RF (System platform), APEX RF Applicator and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Manufacturer | accessdata.fda.gov |
| Massager, Therapeutic, Electric | ISA | 1 | Manufacturer | accessdata.fda.gov |
| Massager, Vacuum, Light Induced Heating | NUV | 2 | Manufacturer | accessdata.fda.gov |
| Massager, Vacuum, Radio Frequency Induced Heat | PBX | 2 | Manufacturer | accessdata.fda.gov |
| Powered Laser Surgical Instrument | GEX | 2 | Manufacturer | accessdata.fda.gov |
| Powered Light Based Non-Laser Surgical Instrument With Thermal Effect | ONF | 2 | Manufacturer | accessdata.fda.gov |
| Stimulator, Electrical, Non-Implantable, For Incontinence | KPI | 2 | Manufacturer | accessdata.fda.gov |
| Stimulator, Muscle, Powered | IPF | 2 | Manufacturer | accessdata.fda.gov |
| Stimulator, Nerve, Transcutaneous, For Pain Relief | GZJ | 2 | Manufacturer | accessdata.fda.gov |
| Vibrator For Therapeutic Use, Genital | KXQ | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 15, 2026 | K251254 | Ignite RF System | GEI | Substantially Equivalent | InMode , Ltd. | accessdata.fda.gov |
| June 26, 2025 | K251632 | Optimas MAX System | GEX | Substantially Equivalent | InMode , Ltd. | accessdata.fda.gov |
| November 14, 2024 | K242598 | DEFINE System (AG612444A) | PBX | Substantially Equivalent | InMode , Ltd. | accessdata.fda.gov |
| July 24, 2024 | K240780 | InMode RF System | GEI | Substantially Equivalent | InMode , Ltd. | accessdata.fda.gov |
| June 13, 2024 | K240017 | InMode System with the Morpheus8 90 Applicator | GEI | Substantially Equivalent | InMode , Ltd. | accessdata.fda.gov |
| March 20, 2024 | K233642 | InMode RF System | GEI | Substantially Equivalent | InMode , Ltd. | accessdata.fda.gov |
| October 13, 2023 | K231495 | The Evolve System with the Transform Applicator | GEI | Substantially Equivalent | InMode , Ltd. | accessdata.fda.gov |
| July 20, 2023 | K231790 | The InMode System with the Morpheus8 Applicators | GEI | Substantially Equivalent | InMode , Ltd. | accessdata.fda.gov |
| June 30, 2022 | K221571 | InMode Multi-system | GEX | Substantially Equivalent | InMode , Ltd. | accessdata.fda.gov |
| July 19, 2021 | K210877 | Evolve System with the T3 Applicator | PBX | Substantially Equivalent | InMode , Ltd. | accessdata.fda.gov |
| July 12, 2021 | K210492 | InMode RF Pro System | GEI | Substantially Equivalent | Inmode MD , Ltd. | accessdata.fda.gov |
| March 5, 2021 | K201285 | InMode Evolve System with the Tone Applicator | IPF | Substantially Equivalent | InMode , Ltd. | accessdata.fda.gov |
| July 22, 2020 | K201150 | InMode RF Multi-System | GEI | Substantially Equivalent | InMode , Ltd. | accessdata.fda.gov |
| July 2, 2020 | K200947 | InMode System with the Morhpeus8 Applicators | GEI | Substantially Equivalent | InMode , Ltd. | accessdata.fda.gov |
| May 5, 2020 | K200293 | InMode System with vTone Applicator | KPI | Substantially Equivalent | InMode , Ltd. | accessdata.fda.gov |
| December 27, 2019 | K192695 | InMode System with the Morpheus8 (Fractora) Applicators | GEI | Substantially Equivalent | Inmode MD , Ltd. | accessdata.fda.gov |
| December 17, 2019 | K192249 | InMode System with Tone Applicator | IPF | Substantially Equivalent | InMode , Ltd. | accessdata.fda.gov |
| October 29, 2019 | K191855 | EmFace Device | PBX | Substantially Equivalent | Inmode MD , Ltd. | accessdata.fda.gov |
| June 20, 2019 | K183450 | EmBody System | PBX | Substantially Equivalent | Inmode MD , Ltd. | accessdata.fda.gov |
| September 26, 2018 | K182325 | InMode RF System | GEI | Substantially Equivalent | Inmode MD , Ltd. | accessdata.fda.gov |
| June 14, 2018 | K180719 | InMode Diolaze System | GEX | Substantially Equivalent | Inmode MD , Ltd. | accessdata.fda.gov |
| June 1, 2018 | K180189 | InMode System with Fractora3D/3D-90 Applicators | GEI | Substantially Equivalent | Inmode MD , Ltd. | accessdata.fda.gov |
| February 23, 2018 | K173677 | InMode VLaze | GEX | Substantially Equivalent | Inmode MD , Ltd. | accessdata.fda.gov |
| December 8, 2017 | K172302 | InMode PLUS System | PBX | Substantially Equivalent | Inmode MD , Ltd. | accessdata.fda.gov |
| October 10, 2017 | K171593 | InMode RF System | GEI | Substantially Equivalent | Inmode MD , Ltd. | accessdata.fda.gov |
| August 7, 2017 | K170738 | InMode Diolaze XL | GEX | Substantially Equivalent | Inmode MD , Ltd. | accessdata.fda.gov |
| December 12, 2016 | K163190 | InMode RF System | GEI | Substantially Equivalent | Inmode MD , Ltd. | accessdata.fda.gov |
| August 19, 2016 | K160329 | InMode System MiniFX Handpiece | PBX | Substantially Equivalent | Inmode MD , Ltd. | accessdata.fda.gov |
| July 12, 2016 | K153568 | InMode Plus System | PBX | Substantially Equivalent | Inmode MD , Ltd. | accessdata.fda.gov |
| February 19, 2016 | K151793 | InMode RF System | GEI | Substantially Equivalent | Inmode MD , Ltd. | accessdata.fda.gov |
| January 4, 2016 | K151273 | InMode FRF Applicator | GEI | Substantially Equivalent | Inmode MD , Ltd. | accessdata.fda.gov |
| December 3, 2014 | K140926 | INMODE WMFACE DEVICE | GEI | Substantially Equivalent | Inmode MD , Ltd. | accessdata.fda.gov |
| October 8, 2013 | K131362 | INMODE WMBODY DEVICE | NUV | Substantially Equivalent | Inmode MD , Ltd. | accessdata.fda.gov |
| April 2, 2013 | K123860 | INMODE SR IPL DEVICE | ONF | Substantially Equivalent | Inmode MD , Ltd. | accessdata.fda.gov |
| February 27, 2013 | K123682 | INMODE HAIR REMOVAL (HR) DEVICE | GEX | Substantially Equivalent | Inmode MD , Ltd. | accessdata.fda.gov |
| June 2, 2011 | K102461 | FRACTORA | GEI | Substantially Equivalent | Invasix , Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Vibrator For Therapeutic Use, Genital
- All makers of Massager, Vacuum, Light Induced Heating
- All makers of Massager, Therapeutic, Electric
- All makers of Stimulator, Electrical, Non-Implantable, For Incontinence
- All makers of Massager, Vacuum, Radio Frequency Induced Heat
- All makers of Electrosurgical, Cutting & Coagulation & Accessories
Updated January 15, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.