BEUDAMED
    FDA Registration Active 🇨🇳 China

    imene Home Use Hair Removal Device (Model(s):T10A, T10D, T11A)

    Reg #: 3031182672 · FEI: 3031182672 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Shenzhen Mlay Intelligent Technology Co., Ltd.
    Registration Number
    3031182672
    FEI Number
    3031182672
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    201, 301, Building 28, Cuigang Industrial Zone 2, Huaide Community, Fuyong Street, Baoan District
    City
    Shenzhen Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K240264

    Owner / Operator

    Firm Name
    Shenzhen Mlay Intelligent Technology Co.,Ltd.
    Operator Number
    10089650
    Address
    201, 301, Building 28, Cuigang Industrial Zone 2, Huaide Community, Fuyong Street, Baoan District
    City
    Shenzhen
    State
    Guangdong
    Postal Code
    518100
    Country
    CN

    US Agent

    Business Name
    Wiselink Medical inc
    Contact Name
    Nelson Xie
    Address
    666 old country RD STE 201 garden city, NY 11530
    City
    Garden City
    State
    NY
    ZIP
    11530
    Country
    US
    Email
    [email protected]
    Phone
    212 6312558 ext. 110

    Products

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

    Proprietary Names

    imene Home Use Hair Removal Device (Model(s):T10A, T10D, T11A) Mlay Home Use Hair Removal Device (Model(s):T10A, T10B, T10C, T10D, T11A, T15A, T17A, T18A, T14A, T16A, T19A) LuxDuo Home Use Hair Removal Device(Model: T11A) KinseiBeauty Home Use Hair Removal Device (Model(s):T16A, T17A) Wellfun Home Use Hair Removal Device (Model(s):T14A, T15A)

    Establishment Types

    Manufacture Medical Device