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510(k) Data Aggregation

    K Number
    K002319
    Device Name
    PURILENS SALINE SOLUTION
    Manufacturer
    PURILENS, INC.
    Date Cleared
    2000-08-30

    (30 days)

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

    PURILENS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K991965
    Device Name
    PURILENS SYSTEM FOR CLEANING AND DISINFECTING CONTACT LENSES
    Manufacturer
    PURILENS, INC.
    Date Cleared
    1999-10-01

    (113 days)

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

    PURILENS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Purilense System is indicated for the cleaning and disinfection of soft (hydrophilic) contact lenses by means of subsonic agitation to remove lens deposits and microorganisms, and ultraviolet irradiation of the surrounding storage solution for disinfection. The lenses may be stored in the disinfected solution for a period of 24 hours following the cleaning and disinfection cycle.
    Device Description
    The device is a cleaning and disinfection unit for contact lenses. It consists of the Purilens Unit and Purilens Solution. The Purilens Unit is compact, with an upper housing containing a germicidal UV light, and a lower housing which contains a removable, clear cleaning chamber with a lens holder for the contact lenses. A mechanism in the lower portion of the cleaning chamber creates the cleaning turbulence activity. Within the lower housing unit is an electronic control unit which operates the UV light and turbulence vibrating mechanism. The lower unit contains an internal automatic timing device which shuts the unit after its 15 minute cycle. The lens holder consists of a removable basket which houses the contact lenses in separate chambers and is suspended within the cleaning chamber in the lower housing. The removable basket assembly is shielded from the UV light. The cleaning chamber contains an unpreserved saline medium as a storage solution for the contact lenses. The Purilens Solution is a preservative free saline solution which is used to fill the cleaning chamber. The turbulence mechanism is a magnetic pedal suspended on the end of a flexible spring located in the bottom of the cleaning chamber. When activated by the electronic connection, the pedal osillates in a subsonic range of 50 - 120 cycles per second creating a whirlpool effect that swirls the Purilens Solution surrounding the lens baskets and removes debris and microorganisms from the lenses during the 15 minute cycle. UV radiation energy from the upper housing disinfects loosened microorganisms in the solution. Disinfection is accomplished without heating, preservatives, or chemicals. The unit cannot function unless the electrical interlock is complete between the upper and lower housings. An electrical transformer is located on the power cord. The transformer converts house current of 110 VAC to 14 VAC for the purpose of operating the device.
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