BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    Activa Optimum 818 and 518, Sheerwave IPL 360

    Reg #: 3011302631 · FEI: 3011302631 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    4190777 CANADA INC
    Registration Number
    3011302631
    FEI Number
    3011302631
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    4930 Chemin Bois-Franc
    City
    Saint-Laurent Quebec
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K050950

    Owner / Operator

    Firm Name
    4190777 CANADA INC
    Operator Number
    10047721
    Address
    4930 Chemin Bois-Franc
    City
    Saint-Laurent
    State
    Quebec
    Postal Code
    H4S 1A7
    Country
    CA

    US Agent

    Business Name
    ITB HOLDINGS LLC
    Contact Name
    ELIE FRANCIS
    Address
    390 North Orange Avenue, Suite 2300
    City
    Orlando
    State
    FL
    ZIP
    32801
    Country
    US
    Email
    [email protected]
    Phone
    855 3897344 ext. 1

    Products

    Device Name Product Code
    Powered Laser Surgical Instrument GEX

    Proprietary Names

    Activa Optimum 818 and 518, Sheerwave IPL 360

    Establishment Types

    Foreign Private Label Distributor Export Device to the United States But Perform No Other Operation on Device