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510(k) Data Aggregation

    K Number
    K211361
    Device Name
    3N Contact Lenses Adjunct Cleaner
    Manufacturer
    Suzhou 3N Biological Technology Co., Ltd
    Date Cleared
    2022-01-13

    (255 days)

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

    Suzhou 3N Biological Technology Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    3N Contact Lenses Adjunct Cleaner is intended for use as an adjunct in deproteinization and storage for soft hydrophilic contact lenses with only either OPTI-FREE EXPRESS Multi-Purpose Disinfecting Solution or Bausch & Lomb ReNu MultiPlus Multi-Purpose Solution.
    Device Description
    The proposed device, 3N Contact Lenses Adjunct Cleaner, Model TN083 is an electrical cleaner which is intended for use as an adjunct in deproteinization and storage for soft hydrophilic contact lenses using approved contact lens solutions. The 3N Contact Lenses Adjunct Cleaner adopt the principle of protein electrophoresis, take advantage of the characteristics that negatively charged protein in certain environment and swarm towards positive pole in electric field, then the tear protein will be removed from the surface and air holes of contact lens and absorbed by anodic cleaning probe to achieve the goal of cleaning contact lenses. The cleaning components of the 3N Contact Lenses Adjunct Cleaner (Model: TN083) consist of a cleaning unit (Power Base) and a partitioned fluid reservoir functioning as the cleaning chamber. The cleaning chamber is detachably connected to the cleaning unit (power base). In the cleaning chamber, there are two independent cleaning tanks; and there is a cleaning probe on each side of the cleaning tank, namely electrode. In the cleaning unit, the circuit board is fixedly provided with electrode connectors electrically connected to the circuit board. The end of the electrode connector can be stretched and elastically connected with the bottom of the electrode.
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