BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    Q-switched Nd:YAG Laser System

    Reg #: 3005545844 · FEI: 3005545844 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    SILHOUET-TONE CORPORATION
    Registration Number
    3005545844
    FEI Number
    3005545844
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2185 Rue Michelin
    City
    LAVAL Quebec
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K102050

    Owner / Operator

    Firm Name
    Silhouet-Tone Corporation
    Operator Number
    8020371
    Address
    1985 Monterey
    City
    Laval
    State
    Quebec
    Postal Code
    H7L 3T6
    Country
    CA

    US Agent

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

    Products

    Device Name Product Code
    Powered Laser Surgical Instrument GEX

    Proprietary Names

    Q-switched Nd:YAG Laser System

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Export Device to the United States But Perform No Other Operation on Device