BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Johnson & Johnson Surgical Vision, Inc.

    Reg #: 3012236936 · FEI: 3012236936 · Expires 2026
    View on FDA
    Products
    20
    Proprietary Names
    21
    Establishment Types
    2
    Classifications
    20

    Registration Details

    Registration Name
    Johnson & Johnson Surgical Vision, Inc.
    Registration Number
    3012236936
    FEI Number
    3012236936
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    31 Technology Drive, Suite 200
    City
    Irvine
    State
    CA
    ZIP
    92618
    Country
    US

    Regulatory Submissions

    510(k) Number
    K840695
    PMA Number
    P960028

    Owner / Operator

    Firm Name
    Johnson & Johnson Surgical Vision, Inc.
    Operator Number
    10053607
    Address
    31 Technology Dr., Suite 200
    City
    Irvine
    State
    CA
    Postal Code
    92618
    Country
    US
    Correspondent
    Rosanne Melikian

    Products

    Device Name Product Code
    Lens, Multifocal Intraocular MFK
    Unit, Phacofragmentation HQC
    Folders And Injectors, Intraocular Lens (Iol) MSS
    Accessories, Soft Lens Products LPN
    Lens, Guide, Intraocular KYB
    Powered Laser Surgical Instrument GEX
    Keratome, Ac-Powered HNO
    Implant, Eye Valve KYF
    Vitrectomy, Instrument Cutter MLZ
    Device, Irrigation, Ocular Surgery KYG
    Intraocular Lens HQL
    Extended Depth Of Focus Intraocular Lens POE
    Lens, Intraocular, Toric Optics MJP
    Instrument, Vitreous Aspiration And Cutting, Battery-Powered HKP
    Ophthalmic Femtosecond Laser OOE
    Aid, Surgical, Viscoelastic LZP
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Sterilization Wrap Containers, Trays, Cassettes & Other Accessories KCT
    Excimer Laser System LZS
    Cannula, Ophthalmic HMX

    Proprietary Names

    LENS, MULTIFOCAL INTRAOCULAR Unit, phacofragmentation Accessories, soft lens products LENS, GUIDE, INTRAOCULAR Keratome, ac-powered Powered laser surgical instrument IMPLANT, EYE VALVE Vitrectomy, instrument cutter Device, irrigation, ocular surgery intraocular lens Instrument, vitreous aspiration and cutting, battery-powered Ophthalmic femtosecond laser Case, Contact Lens Ultrazyme AID, SURGICAL, VISCOELASTIC ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES Sterilization tray Excimer laser system FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL) Ophthalmic Femtosecond Laser Cannula, Ophthalmic

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device