BEUDAMED
    FDA Registration Active 🇺🇸 United States

    STAAR SURGICAL COMPANY

    Reg #: 2023826 · FEI: 2023826 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    15
    Establishment Types
    3
    Classifications
    6

    Registration Details

    Registration Name
    STAAR SURGICAL COMPANY
    Registration Number
    2023826
    FEI Number
    2023826
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    1911 WALKER AVE.
    City
    MONROVIA
    State
    CA
    ZIP
    91016
    Country
    US

    Regulatory Submissions

    510(k) Number
    K940593
    PMA Number
    P030016

    Owner / Operator

    Firm Name
    STAAR SURGICAL Company
    Operator Number
    2023826
    Address
    1911 WALKER AVE., --
    City
    Monrovia
    State
    CA
    Postal Code
    91016
    Country
    US
    Correspondent
    Magda Michna

    Products

    Device Name Product Code
    Lens, Guide, Intraocular KYB
    Phakic Toric Intraocular Lens QCB
    Lens, Intraocular, Phakic MTA
    Intraocular Lens HQL
    Folders And Injectors, Intraocular Lens (Iol) MSS
    Lens, Intraocular, Toric Optics MJP

    Proprietary Names

    MicroSTAAR Injector System (TM/PM) MicroSTAAR Injector System (TD/PD) EVO+ VISIAN Implantable Collamer Lens EVO+ VISIAN Toric Implantable Collamer Lens EVO VISIAN Toric Implantable Collamer Lens EVO VISIAN Implantable Collamer Lens Implantable Collamer Lens Collamer UVA PC Introcular Lens MICROSTAAR STAAR SURGICAL SILICONE NON-UV ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS MicroSTAAR Injector System (TF/PF) Epiphany Elastimide UVA PC Toric IOL Elastimide UVA PC Intraocular Lens Elastic UVA PC Intraocular Lens

    Establishment Types

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