BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SILHOUET-TONE USA

    Reg #: 1225072 · FEI: 3000205157 · Expires 2026
    View on FDA
    Products
    7
    Proprietary Names
    37
    Establishment Types
    1
    Classifications
    7

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    Registration Details

    Registration Name
    SILHOUET-TONE USA
    Registration Number
    1225072
    FEI Number
    3000205157
    Status
    Active
    Expiry Year
    2026
    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
    Brush, Dermabrasion, Powered GFE
    Table, Examination, Medical, Powered LGX
    Powered Laser Surgical Instrument GEX
    Lamp, Infrared, Therapeutic Heating ILY
    Epilator, High Frequency, Needle-Type KCW
    Chair, Surgical, Ac-Powered GBB
    Chair And Table, Medical KMN

    Proprietary Names

    Vortex Peel Silver Peel Essential Peel Versalis Peel Serenity SBF-4c Laguna Nigel 2011 Newstream massage table 4 Cushions Nevada Electric 4C/32" NewStream Serenity Table Laguna Mist 29" Nevada Electric Cabinet Escape Laguna Mist 32" Nevada Electric 4C/30" Laguna Sand SBF-4C Laguna Sand 30" Elantra Etna Spa One Laguna Edge (2M) Lumimax Soli-Lite LG4 Galileo Evolution5HD Ibis Epilator Needle Blend ST 250 Evolution 7HD Sequential Evolution XHD Evolution ST350 Elite Silver Star Laguna Mist Flex with armrest Elite series MD-100 Elite Bronze Double Hydraulic Elite Bronze Elite Platinum Soma Bora Bora (26" x 72") Soma Borneo 30" (3 cushions) Soma Maldives Table (29" x 77")

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198