BEUDAMED
    FDA Registration Active 🇺🇸 United States

    FRACLIGHT, FRACLIGHT PLUS (SHINY, SHINY PLUS) Micro Pulsed Laser System

    Reg #: 3030230686 · FEI: 3030230686 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    RIVIC, LLC
    Registration Number
    3030230686
    FEI Number
    3030230686
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    460 NE 28th Street, Suite 503
    City
    Miami
    State
    FL
    ZIP
    33137
    Country
    US

    Regulatory Submissions

    510(k) Number
    K181868

    Owner / Operator

    Firm Name
    RIVIC, LLC
    Operator Number
    10089419
    Address
    460 NE 28th Street, Suite 503
    City
    Miami
    State
    FL
    Postal Code
    33137
    Country
    US

    Products

    Device Name Product Code
    Powered Light Based Non-Laser Surgical Instrument With Thermal Effect ONF

    Proprietary Names

    FRACLIGHT, FRACLIGHT PLUS (SHINY, SHINY PLUS) Micro Pulsed Laser System

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198