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510(k) Data Aggregation

    K Number
    K120170
    Device Name
    PROCARE PLUS VITRECTOMY SYSTEM
    Manufacturer
    VISIONCARE DEVICES, INC.
    Date Cleared
    2012-05-30

    (132 days)

    Product Code
    HQE
    Regulation Number
    886.4150
    Why did this record match?
    Applicant Name (Manufacturer) :

    VISIONCARE DEVICES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ProCare Plus™ Vitrectomy System is a portable surgical system intended for use in both anterior and posterior segment (vitrectomy) ophthalmic surgeries. The PROCARE PLUS™ Vitrectomy System is indicated for use in support of the following ophthalmic surgical procedures: Removal of vitreous in cases of vitreous clouding, diabetic vitreal hemorrhaging, trauma, including contusions, penetrations, and intraocular foreign bodies; opacity, inflammation, endophthalmitis (bacterial or fungal), uvitis Removal of lens fragments after cataract surgery; Remove vitreous traction under the retina producing localized or complete retinal detachment; Removal of samples of vitreous for diagnostic purposes, i.e. endophthalmitis; Treatment of vitreous loss during cataract surgery; Clean vitreous strands from the cataract wound; Provide internal illumination for vitreous surgery; Provide air pressure for maintaining intraocular pressure for retinal surgery. The VCD HSP VitCutter and Accessories is a single use (disposable) product intended for use in both anterior and posterior segment (vitrectomy) ophthalmic surgeries when used with a pneumatically-driven vitrectomy system or phacoemulsification system that has a pneumaticallydriven vitrectomy module.
    Device Description
    The ProCare PlusTM Vitrectomy System is a portable surgical system intended for use in both anterior and posterior segment (vitrectomy) ophthalmic surgeries. The ProCare Plus™ Vitrectomy System is an AC powered device with an internal Li-Ion battery that provides backup power in the event that AC power is interrupted. The system is primarily run from one multifunction footswitch which gives the surgeon control over all of the surgical functions. The ProCare Plus Vitrectomy system provides many of the functions required by the ophthalmic surgeon for performing a vitrectomy including vitreous cutting and aspiration, illumination, and fluid-air exchange.
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