BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    INMODE LTD.

    Reg #: 3010511300 · FEI: 3010511300 · Expires 2026
    View on FDA
    Products
    10
    Proprietary Names
    151
    Establishment Types
    1
    Classifications
    10

    Registration Details

    Registration Name
    INMODE LTD.
    Registration Number
    3010511300
    FEI Number
    3010511300
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Tavor Building (POB 533), Shaar Yokneam
    City
    Yokneam Northern
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K170738

    Owner / Operator

    Firm Name
    INMODE LTD.
    Operator Number
    10045478
    Address
    Tavor Building (POB 533), Shaar Yokneam
    City
    Yokneam
    State
    Northern
    Postal Code
    2069206
    Country
    IL

    US Agent

    Business Name
    A.Stein Regulatory Affairs Consulting Company Ltd.
    Contact Name
    Naphtali Deutsch
    Address
    9595 Collins Ave Apt 506
    City
    Surfside
    State
    FL
    ZIP
    33154
    Country
    US
    Email
    [email protected]
    Phone
    888 4433867

    Products

    Device Name Product Code
    Powered Laser Surgical Instrument GEX
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Massager, Vacuum, Light Induced Heating NUV
    Massager, Therapeutic, Electric ISA
    Massager, Vacuum, Radio Frequency Induced Heat PBX
    Stimulator, Electrical, Non-Implantable, For Incontinence KPI
    Stimulator, Nerve, Transcutaneous, For Pain Relief GZJ
    Stimulator, Muscle, Powered IPF
    Powered Light Based Non-Laser Surgical Instrument With Thermal Effect ONF
    Vibrator For Therapeutic Use, Genital KXQ

    Proprietary Names

    InMode Diolaze XL TRITON/ OPTIMAS (system platform) DEFINE InMode System with the Morpheus8 90 Applicator InMode System with the Morpheus 8 Applicators Morpheus 8 PRIME Tip (12 Pin Applicator) Morpheus 8 BODY Tip (40 Pin Applicator) Morpheus 8 T Tip InMode System with the vTone Applicator EMPOWER RF System (System platform) EVOLVE System with the Tone Applicator SR IPL Device LUMECCA 515 LUMECCA 580 OPTIMAS (system platform) T3 Applicator EVOLVE X (Platform system) Transform (T3 Applicator) EVOLVE (Platform system) InMode System with Tone Applicator InModeRF Applicator InModeRF HP101306A Applicator EMBRACE/InModeRF (system platform) The Evolve System with the Transform Applicator WMBody BodyFX CONTOURA/ OPTIMAS (system platform) FORMA LUMECCA 580 PEAK DiolazeXL MAX 810 Fusion Light 755/810 OptimasMAX System LUMECCA 515 PEAK Fusion Dark 810/1064 MORPHEUS8 DEEP MORPHEUS8 VascuLazeMAX PLUS WMFace Forma InMode RF System HP1022B6A HP2539B6A HP172246A HP101306A QUANTUMRF 10 HP102206A HP101396A INMODE RF PRO (System platform) HP172248A FACETITE TURBO HP172206A HP253966A IgniteRF HP060999A HP060909A QUANTUMRF 25 Luxora BODYTITE TURBO HP172296A vTone InMode Multi System Fusion Dark InMode OP VasculazeMAX Fusion Light OptimasMAX OptimasMAX platform LUMECCA I Envision DiolazeXL MAX LUMECCA PEAK Optimas Fractora Fractora 60P Morphiva (InMode Fractora 3D-90 Applicator) InMode System With Fractora3D/3D-90 Applicators Morpheus (InMode Fractora 3D Applicator) Morpheus V (InMode Fractora 3D-90 Applicator & Tip) InMode PLUS System InModeRF HP172248A Applicator InModeRF HP173946A Applicator InModeRF HP172246A Applicator BodyTite EMBRACE InModeRF Aviva AccuTite EMBRACE (System platform) InMode RF PRO (System platform) InMode RF (System platform) BodyTite Pro Votiva InMode RF PRO (System Platform) Forma-i Applicator iForma Applicator ENVISION (System platform) i-Forma Applicator EMPOWER (System platform) CellulTite system Cellutite APEX RF (System platform) Morpheus8C Handpiece APEX RF Applicator EMFace EVOKE InMode Diolaze XL (system platform) InMode Diolaze XL 810nm Hand piece (FDA cleared in K170738) InMode Diolaze XL 755/810nm Hand piece InMode Diolaze XL 810/1064nm Hand piece InMode System MiniFX Handpiece DIOLAZE Hair Removal (HR) Device EmBodyFX TI10 Evolve Trim EmBodyPlus EmBody System Vasculaze InMode VLaze InMode System with the Morpheus8 Applicators Morpheus8 Resurfacing 24 pin Morpheus8 Morpheus8 24 pin Morpheus8 Prime 12 pin Morpheus8 Deep Morpheus8 40 pin InMode RF Multi-System CONTOURA Morpheus Pro InMode Morpheus8 System Morpheus 8 BODY Applicator Morpheus 8 PRIME TIP (12 Pin Applicator) Morpheus 8 FACE TIP (24 Pin Applicator) Morpheus 8 T TIP (T Applicator) EMBRACE/INMODE RF (System platform) AG613055A AG613052A AG613054A AG613056A AG613051A AG613053A HP1722B6A FormaV InMode Plus90 System VOTIVA InMode FRF Applicator InMode FRACTORA/FRF FaceTite FractoraV InModeRF HP172206A Applicator

    Establishment Types

    Manufacture Medical Device