BEUDAMED
    FDA Registration Inactive 🇻🇳 Vietnam

    Powered Light Based Non-Laser Surgical Instrument With Thermal Effect;; Silk’n 7; Silk’n Infinity; Silk’n Infinity Fast

    · Expires 2025
    Products
    3
    Proprietary Names
    8
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    SOLEX HIGH-TECH INDUSTRIES (VIETNAM) COMPANY LIMITED
    Status
    Inactive
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Land Plot CN1.2A, Bac Tien Phong Industrial Zone
    City
    Quang Yen Town Quang Ninh
    Country
    VN

    Regulatory Submissions

    510(k) Number
    K171433

    Owner / Operator

    Firm Name
    SOLEX HIGH-TECH INDUSTRIES (VIETNAM) COMPANY LIMITED
    Operator Number
    10093717
    Address
    Land Plot CN1.2A, Bac Tien Phong Industrial Zone
    City
    Quang Yen Town
    State
    Quang Ninh
    Postal Code
    02220
    Country
    VN
    Correspondent
    Mai Thi Kim Chi

    US Agent

    Business Name
    ABMED MEDICAL TECHNOLOGY INC
    Contact Name
    Hui Hong
    Address
    800 E WISHKAH ST # 1021
    City
    Aberdeen
    State
    WA
    ZIP
    98520
    Country
    US
    Email
    [email protected]
    Phone
    303 8000162

    Products

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

    Proprietary Names

    Powered Light Based Non-Laser Surgical Instrument With Thermal Effect;; Silk’n 7; Silk’n Infinity; Silk’n Infinity Fast Powered Light Based Non-Laser Surgical Instrument With Thermal Effect;; Silk’n 7; Silk’n Infinity; Stimulator, Transcutaneous Electrical, Aesthetic Purposes Powered Light Based Non-Laser Surgical Instrument With Thermal Effect;; Silk’n 7; Silk’n Infinity; Silk’n Infinity Fast; Stimulator, Transcutaneous Electrical, Aesthetic Purposes - Light Based Over The Counter Wrinkle Reduction; Silk’n Infinity Fast; Stimulator, Transcutaneous Electrical, Aesthetic Purposes Light Based Over-The-Counter Hair Removal - Light Based Over The Counter Wrinkle Reduction; Powered Light Based Non-Laser Surgical Instrument With Thermal Effect - Light Based Over The Counter Wrinkle Reduction;

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)