BEUDAMED
    FDA Registration Active 🇺🇸 United States

    POLY Pro

    Reg #: 1318319 · FEI: 1318319 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Medtek Skin Care, Inc.
    Registration Number
    1318319
    FEI Number
    1318319
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    3 Depot St
    City
    HUDSON FALLS
    State
    NY
    ZIP
    12839
    Country
    US

    Regulatory Submissions

    510(k) Number
    K170187

    Owner / Operator

    Firm Name
    MEDTEK Skin Care, Inc.
    Operator Number
    1318319
    Address
    3 DEPOT ST., P.O. Box 230
    City
    Hudson Falls
    State
    NY
    Postal Code
    12839
    Country
    US

    Products

    Device Name Product Code
    Powered Laser Surgical Instrument GEX

    Proprietary Names

    POLY Pro

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198