BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Paragon Vision Sciences, Inc.

    Reg #: 3013398957 · FEI: 3013398957 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    18
    Establishment Types
    2
    Classifications
    5

    Registration Details

    Registration Name
    Paragon Vision Sciences, Inc.
    Registration Number
    3013398957
    FEI Number
    3013398957
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    2120 W. Guadalupe Rd.
    City
    Gilbert
    State
    AZ
    ZIP
    85233
    Country
    US

    Regulatory Submissions

    510(k) Number
    K221768
    PMA Number
    P870024

    Owner / Operator

    Firm Name
    COOPERVISION, INC.
    Operator Number
    9929062
    Address
    6101 Bollinger Canyon Road, Suite 500
    City
    San Ramon
    State
    CA
    Postal Code
    94583
    Country
    US

    Products

    Device Name Product Code
    Lens, Contact (Other Material) - Daily HQD
    Lens, Contact, Orthokeratology, Overnight NUU
    Lens, Contact (Rigid Gas Permeable), Extended Wear MWL
    Case, Contact Lens LRX
    Lens, Contact (Polymethylmethacrylate) HPX

    Proprietary Names

    Acuity 100 with Tangible Hydra-PEG Paragon CRT100 Paragon CRT Paragon RG-4 Paragon CRT Dual Axis FluoroPerm30 HDS HDS100 FluoroPerm92 FluoroPerm60 FluoroPerm151 Paragon Z CRT Paragon Z CRT Dual Axis Paragon HDS100 Paragon HDS Paragon Thin Contact Lens Storage Case Paraperm 02

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device