BEUDAMED
    FDA Registration Active 🇨🇳 China

    Silk’n 7; Silk’n Infinity; Silk’n Infinity Fast; Stimulator, transcutaneous electrical, aesthetic purposes

    Reg #: 3007238544 · FEI: 3007238544 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    XIAMEN SOLEX HIGH-TECH INDUSTRIES CO.,LTD
    Registration Number
    3007238544
    FEI Number
    3007238544
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No. 82 Xiyuan Road, Xinyang Industrial Park, Haicang District
    City
    Xiamen Fujian
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K171433

    Owner / Operator

    Firm Name
    XIAMEN SOLEX HIGH-TECH INDUSTRIES CO.,LTD
    Operator Number
    10060751
    Address
    No. 298 Yangguang West Road, Haicang District,
    City
    Xiamen
    State
    Fujian
    Postal Code
    361022
    Country
    CN
    Correspondent
    Yali Zheng

    US Agent

    Business Name
    Regrek LLC
    Contact Name
    Leeyeo Kee
    Address
    19 Holly Cove Ln.,
    City
    Dover
    State
    DE
    ZIP
    19901
    Country
    US
    Email
    [email protected]
    Phone
    302 6089028

    Products

    Device Name Product Code
    Stimulator, Transcutaneous Electrical, Aesthetic Purposes NFO
    Light Based Over-The-Counter Hair Removal OHT
    Powered Light Based Non-Laser Surgical Instrument With Thermal Effect ONF

    Proprietary Names

    Silk’n 7; Silk’n Infinity; Silk’n Infinity Fast; Stimulator, transcutaneous electrical, aesthetic purposes Light based over the counter wrinkle reduction; Powered light based non-laser surgical instrument with thermal effect;

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)