BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    Omnimax S4

    Reg #: 3006716777 · FEI: 3006716777 · Expires 2025
    View on FDA
    Products
    5
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    5

    Registration Details

    Registration Name
    SHARPLIGHT TECHNOLOGIES LTD.
    Registration Number
    3006716777
    FEI Number
    3006716777
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    33 lazarov st.
    City
    RISHON LEZION Tel Aviv
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K233304

    Owner / Operator

    Firm Name
    SharpLight Technologies Ltd.
    Operator Number
    9094019
    Address
    33 Lazarov St., --
    City
    Rishon Le'Zion
    State
    Central
    Postal Code
    7565435
    Country
    IL
    Correspondent
    Yura - Isacov

    Products

    Device Name Product Code
    Powered Laser Surgical Instrument GEX
    Massager, Vacuum, Light Induced Heating NUV
    Powered Laser Surgical Instrument With MicrobeamFractional Output ONG
    Powered Light Based Non-Laser Surgical Instrument ONE
    Powered Light Based Non-Laser Surgical Instrument With Thermal Effect ONF

    Proprietary Names

    Omnimax S4 Omnimax S3

    Establishment Types

    Manufacture Medical Device