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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
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    NOVANEW RECONDITIONING SYSTEM FOR PROF. USE IN-OFFICE USE ONLY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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

    AI/ML Overview

    I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for a contact lens reconditioning system, and it primarily focuses on regulatory approval rather than a detailed study description with performance metrics, sample sizes, expert qualifications, or ground truth establishment.

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