BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Hyper GP (tisilfocon A) Daily Wear Contact Lens

    Reg #: 1720959 · FEI: 1720959 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    ACCU-LENS, INC.
    Registration Number
    1720959
    FEI Number
    1720959
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    5353 W. Colfax Ave.
    City
    Lakewood
    State
    CO
    ZIP
    80214
    Country
    US

    Regulatory Submissions

    510(k) Number
    K182304

    Owner / Operator

    Firm Name
    Accu-Lens, Inc.
    Operator Number
    10057998
    Address
    5353 W. Colfax Ave.
    City
    Lakewood
    State
    CO
    Postal Code
    80214
    Country
    US

    Products

    Device Name Product Code
    Lens, Contact (Orthokeratology) MUW
    Lens, Contact (Other Material) - Daily HQD

    Proprietary Names

    Hyper GP (tisilfocon A) Daily Wear Contact Lens

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)