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510(k) Data Aggregation

    K Number
    K231106
    Device Name
    Accuject Refra Injector AR2900
    Manufacturer
    Medicel AG
    Date Cleared
    2023-09-19

    (153 days)

    Product Code
    MSS
    Regulation Number
    886.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    Medicel AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ACCUJECT™ REFRA Injector is a device intended to fold and insert STAAR Surgical Collamer Phakic One Piece Intraocular Lenses, Model EVO/EVO+ VISIAN® Implantable Collamer® Lens, for surgical placement in the human eye.
    Device Description
    The Medicel ACCUJECT™ REFRA Injector System, Model AR2900 is to be used by an ophthalmic surgeon and is intended to facilitate the loading, folding and insertion of the STAAR Surgical Collamer Phakic One Piece Intraocular Lenses, Model EVO/EVO+ VISIAN® Implantable Collamer® Lens, for surgical placement in the human eye. The ACCUJECTTM REFRA is a single use device designed specifically to deliver the STAAR Surgical Implantable Collamer® Lenses.
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    K Number
    K101134
    Device Name
    VISIAN NANOPOINT 2.0 INJECTOR MODEL LP604430
    Manufacturer
    MEDICEL AG
    Date Cleared
    2010-08-09

    (109 days)

    Product Code
    MSS
    Regulation Number
    886.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICEL AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Visian® nanoPOINT™ 2.0 Injector System is a device intended to fold and insert STAAR Surgical Collamer® Phakic One Piece Intraocular Lenses, Model Visian® ICL, for surgical placement in the human eye.
    Device Description
    The Visian® nanoPOINT™2.0 Injector System is a sterile, single-use device intended to fold and insert a STAAR Surgical Collamer® Phakic One Piece Intraocular Leas. Model Visian® ICL through surgical procedure in a human eye. The system provides, a tubular pathway through a corneal incision allowing delivery of a phakic IOL into the human eye. This device has 3 basic components: a syringe type injector with a silicone cushion tip plunger, a 33º bevel down cartridge tip and a loading block.
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    K Number
    K092023
    Device Name
    NAVIJECT SUB2-1P, MODEL: LP604430
    Manufacturer
    MEDICEL AG
    Date Cleared
    2009-07-28

    (22 days)

    Product Code
    MSS
    Regulation Number
    886.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICEL AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Naviject Sub2-1P IOL Injector and Cartridge Set for intraocular lenses is indicated for the insertion only of models of intraocular lenses that allow use of this injector in their approved labeling.
    Device Description
    The Naviject Sub2-1P IOL Injector and Cartridge Set is a sterile, single-use device intended to fold and insert a STAAR Surgical Visian ICL phakic intraocular lens through surgical procedure in a human eye. The system provides a tubular pathway through an incision over the iris, allowing delivery of an IOL into the human eye.
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    K Number
    K070669
    Device Name
    IOL INJECTOR SET
    Manufacturer
    MEDICEL AG
    Date Cleared
    2007-11-01

    (234 days)

    Product Code
    KYB
    Regulation Number
    886.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICEL AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Medicel IOL Injector Set and Cartridge for intraocular lenses is indicated for the insertion only of models of intraocular lenses that allow use of this injector in their approved labeling.
    Device Description
    The Medicel IOL Injector Set for intraocular lenses is intended to insert foldable intraocular whose labeling specifies this injector. The injector is available as reusable or single-use. The cartridge is single-use and is provided sterile. The device has two basic components: an injector (available either reusable or single use) and a disposable cartridge, sold sterile. The single-use injector is made of plastic and is sold sterile. The re-usable injector is made of titanium and can be autoclaved. The cartridge is made of lubricated polypropylene.
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    K Number
    K040837
    Device Name
    MULTIJECT INJECTOR AND MICROGLIDE CARTRIDGE
    Manufacturer
    MEDICEL AG
    Date Cleared
    2004-06-17

    (78 days)

    Product Code
    MSS
    Regulation Number
    886.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICEL AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Medicel MultiJect injector for intraocular lenses is intended to insert foldable intraocular lenses CeeOn JI 3A and Tecnis Z9000 made by Pharmacia when used in conjunction with the MicroGlide cartridge. The Medicel MultiJect injector for intraocular lenses is indicated for the insertion of foldable intraocular lenses " Inc. Medicer Manason Mysetting when used in conjunction with the MicroGlide cartridge.
    Device Description
    The Medicel MultiJect injector for intraocular lenses is intended to insert foldable intraocular Jenses CeeOn 913A and Tecnis Z9000 made by Pharmacia when used in conjunction with the MicroGlide cartridge. The injector is reusable and can be autoclaved. The cartridge is single-use and is provided sterile. Two types of injectors are provided: a syringe type and a screw type. The MultiJect is designed to be used with the Pharmacia Tecnis Z9000 lenses and the Pharmacia CeeOn 913A lenses. The device has two components: a reusable injector and a disposable cartridge, sold sterile. The injector is made of titanium. The injector can be autoclaved. The cartridge is made of lubricated polypropylene.
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