BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    Optimas

    Reg #: 3010511300 · FEI: 3010511300 · Expires 2025
    View on FDA
    Products
    6
    Proprietary Names
    14
    Establishment Types
    1
    Classifications
    6

    Registration Details

    Registration Name
    INMODE LTD.
    Registration Number
    3010511300
    FEI Number
    3010511300
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Tavor Building (POB 533), Shaar Yokneam
    City
    Yokneam Northern
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K221571

    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
    9559 COLLINS AVE, APARTMENT 1007
    City
    Surfside
    State
    FL
    ZIP
    33154
    Country
    US
    Email
    [email protected]
    Phone
    888 4433867

    Products

    Device Name Product Code
    Massager, Therapeutic, Electric ISA
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Powered Laser Surgical Instrument GEX
    Massager, Vacuum, Radio Frequency Induced Heat PBX
    Massager, Vacuum, Light Induced Heating NUV
    Powered Light Based Non-Laser Surgical Instrument With Thermal Effect ONF

    Proprietary Names

    Optimas InMode Multi System Fusion Light Fusion Dark LUMECCA I DiolazeXL MAX VasculazeMAX OptimasMAX platform Morpheus8 Burst Deep InMode OP Envision Morpheus8 Burst LUMECCA PEAK OptimasMAX

    Establishment Types

    Manufacture Medical Device