BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Epic X/10/T-Series

    Reg #: 2027755 · FEI: 2027755 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    BIOLASE MG LLC
    Registration Number
    2027755
    FEI Number
    2027755
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    27042 Towne Centre Drive, Suite 270
    City
    Foothill Ranch
    State
    CA
    ZIP
    92610
    Country
    US

    Regulatory Submissions

    510(k) Number
    K121286

    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
    Lamp, Infrared, Therapeutic Heating ILY
    Powered Laser Surgical Instrument GEX

    Proprietary Names

    Epic X/10/T-Series

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility