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510(k) Data Aggregation

    K Number
    K210300
    Device Name
    VueSonic One Contact Lens Cleaning System, VueSonic Advance 2 Contact Lens Cleaning System
    Manufacturer
    VueSonic, LLC
    Date Cleared
    2021-04-01

    (57 days)

    Product Code
    LYL, MRC
    Regulation Number
    886.5928
    Why did this record match?
    Applicant Name (Manufacturer) :

    VueSonic, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VueSonic One Contact Lens Cleaning System is a cleaning system for Soft and Hybrid contact lenses by mimicking digital rubbing with 3-D sonic Vibration Technology. The VueSonic Advance 2 Contact Lens Cleaning System is a cleaning system for Rigid contact lenses by mimicking digital rubbing with 3-D sonic Vibration Technology.
    Device Description
    The VueSonic One Contact Lens Cleaning System and VueSonic Advance 2 Contact Lens Cleaning Systems are cleaning systems for contact lenses. Both devices consist of a device body, a contact lens holder, which houses the cleaning cushions and the damping heads. The contact lens holder, cleaning cushions and damping heads are made of soft medical silicone, which will not damage the lens. The systems are designed to mimic human hand rubbing. This is done by the 3D multi-frequency modulated stereo power source and corresponding intelligent control circuit, which make a uniform three-dimensional relative movement between the damping heads and cleaning cushion. The proposed device consists of two versions: - For Rigid Lenses, VueSonic Advance 2 Contact Lens Cleaning System; and - For Soft and Hybrid Lenses, VueSonic One Contact Lens Cleaning System.
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