BEUDAMED
    FDA Registration Active 🇩🇰 Denmark

    AdvaLight APS

    Reg #: 3010683226 · FEI: 3010683226 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    AdvaLight APS
    Registration Number
    3010683226
    FEI Number
    3010683226
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Industriparken 22 A
    City
    Ballerup Hovedstaden
    Country
    DK

    Regulatory Submissions

    510(k) Number
    K132976

    Owner / Operator

    Firm Name
    AdvaLight APS
    Operator Number
    10046794
    Address
    Industriparken 22A
    City
    Ballerup
    State
    Hovedstaden
    Postal Code
    DK-2750
    Country
    DK
    Correspondent
    Christian Helms-Olesen

    US Agent

    Business Name
    DEL MAR TECHNOLOGIES INC
    Contact Name
    Jan Enemaerke
    Address
    300 Enterprise Street, Suite G
    City
    Escondido
    State
    CA
    ZIP
    92029
    Country
    US
    Email
    [email protected]
    Phone
    760 7989550

    Products

    Device Name Product Code
    Powered Laser Surgical Instrument GEX

    Proprietary Names

    ADVATx ADVAFx

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198