BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Glaukos Corporation

    Reg #: 3012833022 · FEI: 3012341472 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    8
    Establishment Types
    3
    Classifications
    5

    Registration Details

    Registration Name
    Glaukos Corporation
    Registration Number
    3012833022
    FEI Number
    3012341472
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    229 Avenida Fabricante
    City
    San Clemente
    State
    CA
    ZIP
    92672
    Country
    US

    Regulatory Submissions

    510(k) Number
    K220032
    PMA Number
    P170043

    Owner / Operator

    Firm Name
    GLAUKOS CORP.
    Operator Number
    9050364
    Address
    One Glaukos Way, --
    City
    Aliso Viejo
    State
    CA
    Postal Code
    92656
    Country
    US
    Correspondent
    David - Fernquist

    Products

    Device Name Product Code
    Knife, Ophthalmic HNN
    Intraocular Pressure Lowering Implant OGO
    Implant, Eye Valve KYF
    Ring, Ophthalmic (Flieringa) HNH
    Trephine, Manual, Ophthalmic HRH

    Proprietary Names

    iAccess Precision Blade iStent inject Trabecular Micro-Bypass System, Model G2-M-IS iStent inject W Trabecular Micro-Bypass System, Model G2-W iStent inject W Trabecular Micro-Bypass System with Infinite Injector Technology, Model iS2 iStent infinite Trabecular Micro-Bypass System Model iS3 iprism CLIP iStent Trabecular Micro-Bypass Stent System iAccess Trabecular Trephine

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device