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510(k) Data Aggregation

    K Number
    K103495
    Device Name
    ASICO SOFTIP INJECTOR SYSTEM
    Manufacturer
    ASICO LLC
    Date Cleared
    2011-06-29

    (212 days)

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

    ASICO LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ASICO SofTip Injector system is a sterile, single use device intended to insert a foldable intraocular lens through a surqical procedure in a Human eye. The system provides a tubular pathway through a incision , allowing the delivery of a IOL into the Human eye. This is indicated for the insertion only of models of intraocular lens that allow use of this injector in their approved labelling
    Device Description
    The ASICO SofTip Injector system is a sterile, single use device intended to insert a foldable intraocular lens through a surqical procedure in a Human eye. The system provides a tubular pathway through a incision, allowing the delivery of a IOL into the Human eye. This is indicated for the insertion only of models of intraccular lens that allow use of this injector in their approved labelling. The plunger's head is covered by a silicone cushion that provide a good contact to the lens to ensure a smooth delivery. The plunger is advanced by direct forward motion applied to the syringe type plunger. The set consists of a disposable injector, a cartridge and a silicone tip. There are different Injector sets based on the type of cartridge that is used (AS-9300-16, AS-93001620, AS-9300-24,AS-9300-2420). The product is manufactured according to the ISO 13485:2003 Quality Standards and Quality System Requlations. The Injector body is manufactured from Polycarbonate 144R Blue. The plunger assembly which consists of plunger, shaft and outer and inner cap is made up of, Polycarbonate 144R white and the spring is made of stainless steel (SS304) under validated conditions. The cartridge is made from medical grade lubricated polypropylene and the silicon tip is also from medical grade. The injector system will be delivered sterile.
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    K Number
    K073010
    Device Name
    ROYALE AE 9036 LSP INJECTOR
    Manufacturer
    ASICO LLC
    Date Cleared
    2007-11-07

    (13 days)

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

    ASICO LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Royale® AE-9036 LSP Injectors are reusable instruments to assist in implanting Alcon ACRYSOF® foldable intraocular lenses during a normal small incision cataract surgery. They are designed to incorporate Monarch III cartridges D and Monarch II cartridge C for foldable intraocular lenses. The cartridges are loaded into the injector body. By pushing the piston, the lens will be removed out of the cartridge and delivered to the desired position.
    Device Description
    The injectors are autoclavable, reusable titanium hand pieces which are used to deliver folded intraocular lenses into the eye for replacement of the human crystalline lens. They are a modification to the previously cleared Injector Royale AE 9045 K023737. The injector reusable hand piece accepts the cartridges with a sterile single use cartridge which incorporates the folded lens and delivers the lens by using a plunger to express the lens. The plunger's head is contoured to provide a good contact to the lens as well as an adequate clearance for the trailing haptic. The plunger is advanced by direct forward motion applied to the syringe type plunger. Due to the ball bearing technology a smooth and well controlled lens delivery is ensured.
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