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510(k) Data Aggregation

    K Number
    K022186
    Device Name
    SCLERAL PLUGS, 19 AND 20 GAUGE
    Manufacturer
    MICROVISION, INC.
    Date Cleared
    2003-02-26

    (236 days)

    Product Code
    LXP
    Regulation Number
    886.4155
    Why did this record match?
    Applicant Name (Manufacturer) :

    MICROVISION, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The scleral plugs are intended to maintain patency of a previously made incision in the sclera of the eye, during ophthalmic surgical procedures.
    Device Description
    Scleral plugs, 19 and 20 gauge, for use in ophthalmic surgical procedures. Both 19 and 20 gauge plugs are stainless steel. The 19 gauge plugs are gold plated.
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    K Number
    K023481
    Device Name
    MICROVISION SCLERAL BUCKLING COMPONENTS
    Manufacturer
    MICROVISION, INC.
    Date Cleared
    2003-01-08

    (83 days)

    Product Code
    HQX
    Regulation Number
    886.3340
    Why did this record match?
    Applicant Name (Manufacturer) :

    MICROVISION, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MicroVision Scleral Buckling Components are solid silicone and silicone sponge implants intended for intrascleral and episcleral buckling in the surgical treatment of retinal detachments.
    Device Description
    The MicroVision Scleral Buckling Components are molded solid silicone and silicone sponge devices available in a variety of shapes and sizes. The components are provided as sterile for single use only. Biocompatibility testing conducted according to ISO 10993 confirmed that the components are biocompatible and nontoxic.
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    K Number
    K982462
    Device Name
    FIBER OPTIC ENDOILLUMINATION PROBE
    Manufacturer
    MICROVISION, INC.
    Date Cleared
    1998-09-14

    (61 days)

    Product Code
    FFS
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    MICROVISION, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Fiber Optic Endoillumination Probe is indicated for intraocular illumination in vitreoretinal surgery.
    Device Description
    The Fiber Optic Endoillumination Probe is provides intraocular illumination. The light is transmitted from the source to the inside of the eye through a flexible optical fiber, which has been threaded through an illumination probe.
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