BEUDAMED
    FDA Registration Active 🇸🇮 Slovenia

    Philips Lumea, IPL

    Reg #: 3026360847 · FEI: 3026360847 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    ISKRA MEHANIZMI D.O.O.
    Registration Number
    3026360847
    FEI Number
    3026360847
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Zgornji Brnik 400
    City
    Brnik-Aerodrom
    Country
    SI

    Regulatory Submissions

    510(k) Number
    K243453

    Owner / Operator

    Firm Name
    Iskra Mehanizmi D.O.O.
    Operator Number
    10093436
    Address
    Zgornji Brnik 400
    City
    Brnik-Aerodrom
    State
    SI-NOTA
    Postal Code
    4210
    Country
    SI

    US Agent

    Business Name
    Registrar Corp
    Contact Name
    David Lennarz
    Address
    144 Research Dr
    City
    Hampton
    State
    VA
    ZIP
    23666
    Country
    US
    Email
    [email protected]
    Phone
    757 2240177

    Products

    Device Name Product Code
    Light Based Over-The-Counter Hair Removal OHT
    Powered Laser Surgical Instrument GEX

    Proprietary Names

    Philips Lumea, IPL

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)