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510(k) Data Aggregation

    K Number
    K023623
    Device Name
    NOVAVISION, MODEL 2.0
    Manufacturer
    NOVAVISION, INC.
    Date Cleared
    2003-04-22

    (175 days)

    Product Code
    HPT, LQD
    Regulation Number
    886.1605
    Why did this record match?
    Applicant Name (Manufacturer) :

    NOVAVISION, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    NovaVision™ is intended for the diagnosis and improvement of visual functions in patients with impaired vision that may result from trauma, stroke, inflammation, surgical removal of brain tumors or brain surgery, and may also be used to improve visual function in patients with amblyopia.
    Device Description
    NovaVision™ consists of two computer software programs: (1) one intended for health care professionals - for the precise diagnosis of patients' visual deficiencies, the development of patient-specific therapy programs, and the analysis of results of patient therapy (NovaVision™ Diagnosis Software and Training Program); and (2) one intended for patients - therapeutic software for use by patients in their homes to train and improve impaired visual functions (NovaVision™-Therapy).
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    K Number
    K960584
    Device Name
    NOVANEW RECONDITIONING SYSTEM FOR PROF. USE IN-OFFICE USE ONLY
    Manufacturer
    NOVAVISION, INC.
    Date Cleared
    1996-08-15

    (185 days)

    Product Code
    HQD
    Regulation Number
    886.5916
    Why did this record match?
    Applicant Name (Manufacturer) :

    NOVAVISION, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Nova-New Lens Re-hydrophilization System is indicated for use for the in-office only re-hydrophilization of NOVAWET, PERCEPTION and VANGUARD rigid gas permeable contact lenses for daily wear. The Nova-New Lens Re-hydrophilization System permits the eye care practitioner to modify the surface of the contact lens.
    Device Description
    Not Found
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    K Number
    K955900
    Device Name
    NOVALENS/NOVAWET SPHJERICAL & PERCEPTION & VANGUARD MULTIFOCAL &/OR BIFOCAL (ROSIFOCON A) RIGID GAS PERMEABLE CONTACT LR
    Manufacturer
    NOVAVISION, INC.
    Date Cleared
    1996-03-25

    (87 days)

    Product Code
    HQD
    Regulation Number
    886.5916
    Why did this record match?
    Applicant Name (Manufacturer) :

    NOVAVISION, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Not Found
    Device Description
    NOVALENS/NovaWet spherical and PERCEPTION and VANGUARD multifocal and/or bifocal (rosilfocon A) Rigid Gas Permeable Contact Lens (Clear and Blue Tinted) for Daily Wear (shipped in NovaSoak.
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