BEUDAMED
    FDA Registration Active 🇨🇳 China

    Hand-held IPL device (IPL Home Use Hair Removal Device), Model: FZ-608, FZ-608G, FZ-100, FZ-200

    Reg #: 3026132991 · FEI: 3026132991 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Shenzhen IONKA Medical Technology Co., Ltd.
    Registration Number
    3026132991
    FEI Number
    3026132991
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Room 601, No. 3, Jiazitang Second Industrial Zone, Jiazitang Community, Fenghuang Street, Guangming District
    City
    Shenzhen Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K230739

    Owner / Operator

    Firm Name
    Shenzhen IONKA Medical Technology Co., Ltd.
    Operator Number
    10086648
    Address
    Room 601, No. 3, Jiazitang Second Industrial Zone, Jiazitang Community, Fenghuang Street, Guangming District
    City
    Shenzhen
    State
    Guangdong
    Postal Code
    518132
    Country
    CN
    Correspondent
    Dongfa Chen

    US Agent

    Business Name
    Simply Shipped, LLc
    Contact Name
    Mike Ryan
    Address
    12745 W Townsend St
    City
    Brookfield
    State
    WI
    ZIP
    53005
    Country
    US
    Email
    [email protected]
    Phone
    414 3264114

    Products

    Device Name Product Code
    Light Based Over-The-Counter Hair Removal OHT

    Proprietary Names

    Hand-held IPL device (IPL Home Use Hair Removal Device), Model: FZ-608, FZ-608G, FZ-100, FZ-200

    Establishment Types

    Manufacture Medical Device