BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Soli-Lite LG4 Galileo

    Reg #: 1225072 · FEI: 3000205157 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    SILHOUET-TONE USA
    Registration Number
    1225072
    FEI Number
    3000205157
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    7227 NW 54TH ST
    City
    Miami
    State
    FL
    ZIP
    33166
    Country
    US

    Regulatory Submissions

    510(k) Number
    K192755

    Owner / Operator

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

    Products

    Device Name Product Code
    Powered Laser Surgical Instrument GEX
    Lamp, Infrared, Therapeutic Heating ILY

    Proprietary Names

    Soli-Lite LG4 Galileo Lumimax

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198