BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Waterlase iPlus with Fractional Handpiece

    Reg #: 3017125161 · FEI: 3017125161 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    BIOLASE MG LLC
    Registration Number
    3017125161
    FEI Number
    3017125161
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    4225 Prado Road, Suite 102
    City
    Corona
    State
    CA
    ZIP
    92880
    Country
    US

    Regulatory Submissions

    510(k) Number
    K210183

    Owner / Operator

    Firm Name
    MEGAGEN IMPLANT CO. LTD
    Operator Number
    9067358
    Address
    45, Secheon-ro 7-gil, Dasa-eup, Dalseong-gun
    City
    Daegu
    State
    KR-NOTA
    Postal Code
    42921
    Country
    KR
    Correspondent
    Kwang Bum Park

    Products

    Device Name Product Code
    Powered Laser Surgical Instrument GEX
    Powered Laser Surgical Instrument With MicrobeamFractional Output ONG

    Proprietary Names

    Waterlase iPlus with Fractional Handpiece

    Establishment Types

    Manufacture Medical Device