BEUDAMED
    FDA Registration Active 🇸🇮 Slovenia

    FOTONA D.O.O.

    Reg #: 9613462 · FEI: 1000597018 · Expires 2026
    View on FDA
    Products
    9
    Proprietary Names
    12
    Establishment Types
    1
    Classifications
    9

    Registration Details

    Registration Name
    FOTONA D.O.O.
    Registration Number
    9613462
    FEI Number
    1000597018
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    STEGNE 7,
    City
    LJUBLJANA
    Country
    SI

    Regulatory Submissions

    510(k) Number
    K090126

    Owner / Operator

    Firm Name
    FOTONA D.O.O.
    Operator Number
    9032993
    Address
    STEGNE 7
    City
    LJUBLJANA
    State
    SI-061
    Postal Code
    1000
    Country
    SI
    Correspondent
    MARKO - BERDAJS

    US Agent

    Business Name
    Fotona LLC
    Contact Name
    Jeremy Desrosiers
    Address
    4343 W Royal Ln Ste 116
    City
    Irving
    State
    TX
    ZIP
    75063
    Country
    US
    Email
    [email protected]
    Phone
    972 5989000

    Products

    Device Name Product Code
    Powered Laser Surgical Instrument GEX
    Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis PDZ
    Stimulator, Muscle, Powered, For Muscle Conditioning NGX
    Stimulator, Muscle, Powered IPF
    Laser, Dental, Soft Tissue NVK
    Lamp, Infrared, Therapeutic Heating ILY
    Electromagnetic Stimulator, Pain Relief QPL
    Powered Laser Surgical Instrument With MicrobeamFractional Output ONG
    Stimulator, Electrical, Non-Implantable, For Incontinence KPI

    Proprietary Names

    Fotona XP Nd:YAG Laser System Family AvalancheLase Family SkyPulse Laser Platform StarFormer StarWalker LightWalker Laser System Family Fotona Lightwalker Laser System Family QuantumStar StarFormer (M008-3T) Fotona Dynamis Fotona XP Plus Nd:YAG Family Dynamis Pro Family

    Establishment Types

    Manufacture Medical Device