BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ACCULENS, INC.

    Reg #: 1720959 · FEI: 1720959 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    8
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    ACCULENS, INC.
    Registration Number
    1720959
    FEI Number
    1720959
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    5353 W. Colfax Ave.
    City
    Lakewood
    State
    CO
    ZIP
    80214
    Country
    US

    Regulatory Submissions

    510(k) Number
    K230910

    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 (Other Material) - Daily HQD
    Lens, Contact (Orthokeratology) MUW

    Proprietary Names

    Optimum Gp Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses Optimum Gp Ok Optimum Gp with Hpt Optimum Gp Modification Optimum Hr-1.51 and Hr-1.53 Hyper GP (tisilfocon A) Daily Wear Contact Lens NewVision

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device