BEUDAMED
    FDA Registration Active 🇭🇰 Hong Kong

    VISTAKON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS, CLEAR AND TINTED (VISIBILITY AND/OR COSMETICALLY)

    Reg #: 3012546757 · FEI: 3012546757 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    BOLD VISION GROUP LIMITED
    Registration Number
    3012546757
    FEI Number
    3012546757
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Room 1303, 13/F, Multifield Commercial Centre, 426 Shanghai Street, Mongkok
    City
    Hong Kong
    Country
    HK

    Regulatory Submissions

    510(k) Number
    K062614

    Owner / Operator

    Firm Name
    Bold Vision Group Limited
    Operator Number
    10052103
    Address
    Room 1303, 13/F, Multifield Commercial Centre, 426 Shanghai Street, Mongkok
    City
    Hong Kong
    State
    HK-NOTA
    Postal Code
    00000
    Country
    HK
    Correspondent
    Mika T Viljakainen

    US Agent

    Business Name
    FDA Solutions Group LLC
    Contact Name
    Larry Ordet
    Address
    5835 Waterford District Dr Ste 200
    City
    Doral
    State
    FL
    ZIP
    33126
    Country
    US
    Email
    [email protected]
    Phone
    305 7023161

    Products

    Device Name Product Code
    Lenses, Soft Contact, Daily Wear LPL

    Proprietary Names

    VISTAKON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS, CLEAR AND TINTED (VISIBILITY AND/OR COSMETICALLY)

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device