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510(k) Data Aggregation

    K Number
    K090161
    Device Name
    EPIPHANY INJECTION SYSTEM
    Manufacturer
    STAAR SURGICAL CO.
    Date Cleared
    2009-06-09

    (138 days)

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

    STAAR SURGICAL CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Epiphany Injector System is a device intended to fold and insert STAAR Surgical Company aspheric three piece Collamer®, Model CQ2015A, and aspheric three piece silicone intraocular lenses, Model AQ2015A, for surgical placement in the human eye.
    Device Description
    The single use, disposable Epiphany Injector System is a delivery system for intraocular lenses (IOLs) for surgical placement in the human eye. The two main materials used in the manufacturer of this injector system will be polycarbonate and polypropylene. All product is also supplied "STERILE."
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    K Number
    K073586
    Device Name
    MICROSTAAR INDIGO INJECTOR FOAM TIP SYSTEM
    Manufacturer
    STAAR SURGICAL CO.
    Date Cleared
    2008-03-13

    (84 days)

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

    STAAR SURGICAL CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MicroSTAAR ™ Indigo Injector Foam Tip System is a device intended to fold and insert STAAR Surgical one and three piece Collamer® lenses for surgical placement in the human eye.
    Device Description
    Not Found
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    K Number
    K073591
    Device Name
    MICROSTAAR MSI INJECTOR FOAM TIP SYSTEM
    Manufacturer
    STAAR SURGICAL CO.
    Date Cleared
    2008-03-13

    (84 days)

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

    STAAR SURGICAL CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MicroSTAAR ™ MSI Injector Foam Tip System is a device intended to fold and insert STAAR Surgical one and three piece Collamer® lenses for surgical placement in the human eye.
    Device Description
    Not Found
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    K Number
    K032412
    Device Name
    RE-USEABLE MICROSTAAR INJECTOR, MSI-S
    Manufacturer
    STAAR SURGICAL CO.
    Date Cleared
    2004-06-10

    (310 days)

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

    STAAR SURGICAL CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Collamer 3 Piece IOL Injector, is an intraocular lens guide used to ford and into the capsular bag or ciliary sulcus following cataract extraction.
    Device Description
    The Collamer 3 Piece Injector is made of titanium alloy designed for inserting intraocular lenses into the human eye following cataract extraction. The Collamer 3 Piece Injector materials and mechanical behavior are similar to those used with the predicate device.
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    K Number
    K020734
    Device Name
    SURGE-FREE ASPIRATION ADAPTER
    Manufacturer
    STAAR SURGICAL CO.
    Date Cleared
    2002-05-16

    (71 days)

    Product Code
    HQC
    Regulation Number
    886.4670
    Why did this record match?
    Applicant Name (Manufacturer) :

    STAAR SURGICAL CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Surge-free Aspiration Adapter is a filter protected flow restriction orifice used during cataract surgery to prevent/neutralize vacuum surges in the aspiration line.
    Device Description
    The Surge-free Aspiration Adapter is a filter protected flow restriction device intended to be placed between the handpiece and aspiration tubing used during phacoemulsification surgery. The Surge-free Aspiration Adapter prevents/neutralizes vacuum surges in the aspiration line resulting from the sudden clearing of occlusions.
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    K Number
    K983129
    Device Name
    DISPOSABLE MICROSTAAR INJECTOR (MODEL MSI-P1)
    Manufacturer
    STAAR SURGICAL CO.
    Date Cleared
    1998-12-04

    (87 days)

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

    STAAR SURGICAL CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Disposable MicroSTAAR™ Injector (Model MSI-P1) is a device used to fold and insert STAAR Surgical UV-ELASTICT™ silicone lenses for surgical placement in the human eye. The Disposable MicroSTAAR™ Injector is a device used to fold and insert STAAR Surgical Company UV-ELASTIC™ single-piece silicone lenses for surgical placement in the human eye.
    Device Description
    The Disposable MicroSTAART™ Injector (Model MSI-P1) is used to fold and insert STAAR Surgical UV-ELASTICTM silicone intraocular lenses for surgical placement in the human eye. Like other MicroSTAAR injectors it provides a sterile tubular pathway through a surgical incision, over the iris and into either the ciliary sulcus or the capsular bag of the eye. The Disposable MicroSTAART™ Injector (Model MSI-P1) is made from plastic and the inner dimensions of the delivery pathway, as well as the outer dimensions of the portion that contacts the eye tissues are identical to STAAR Surgical Company's currently marketed injection systems. The Disposable MicroSTAART™Injector (Model MSI-P1) is provided sterile and is designed for single use.
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    K Number
    K980696
    Device Name
    FOAM TIP INJECTOR
    Manufacturer
    STAAR SURGICAL CO.
    Date Cleared
    1998-09-11

    (200 days)

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

    STAAR SURGICAL CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Foam Tip™ Injector is a device used to fold and insert STAAR Surgical UV-ELASTIC™ silicone lenses for surgical placement in the human eye.
    Device Description
    STAAR Surgical Company's Foam Tip™ Injector is used to fold and insert STAAR Surgical UV-ELASTIC™ silicone intraocular lenses for surgical placement into the human eye. The new Foam Tip™ Injector utilizes the same design principles (i.e. a plunger pushing or threaded mechanism) to push the IOL through a cartridge for injection into the eye as the existing MicroSTAART™ injectors. The new injector system differs from the MicroSTAART™ injector in that it contains a disposable Foam Tip™ plunger insert which may be attached to the sterilized injector body prior to lens loading. This attachable Foam Tip™ plunger insert is encapsulated inside a holder that protects the sponge from damage. The holder acts to guide the plunger as it slides into the injector body and performs as a wrench to remove the plunger from the injector once the lens has been implanted. Once the sponge portion of the foam plunger insert is hydrated, it enables the surgeon to have greater control in ejecting the lens properly through the cartridge and into the eye. Like the existing MicroSTAAR™ injectors, the new Foam Tip™ Injector body is provided sterile and can be resterilized for multiple use. The new Foam Tip™ plunger insert is also provided sterile but is intended for single use only.
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