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510(k) Data Aggregation

    K Number
    K974724
    Device Name
    SOFTMATE AUTOMATIC LENS CLEANING UNIT, CLENSATRON 700 CL AUTOMATIC CONTACT LENS CLEANER, VISONIC DOME, LENSONIC CONTACT
    Manufacturer
    LENS COMFORT, INC.
    Date Cleared
    1998-03-02

    (74 days)

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

    LENS COMFORT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The New Comfort Contact Lens Care Accessory is intended for use in conjunction with contact lens solutions as an accessory in the cleaning of contact lenses. The New Comfort Contact lens Care Accessory is indicatod as aid for cleaning as an accessory for soft hydrophilic lenses and gas pormoablo lonsos whon usod with the appropriate Allergan® Soft Mate® solutions such as the Consept® Cleaning and Disinfoction Systom which is comprisod of the Allergan® Soft Mato® Consept®-1 Cleaning and Disinfecting solution and Allergen® Soft Mate® Consept - 2 Neutralizing and Rinsing Solution or Spray. The New Comfort Contact Lens Care Accessory is indicated for use for gas permeable solutions such as Allergan® Gas Permeable Daily Cleaner and Allergan® ComfortCare GP Wetting and Soaking Solution. The New Comfort Contact Lens Care Accessory may be used for a receptacle for chemical disinfection.
    Device Description
    The New Comfort Ultrasonic Contact Lens Care Accessory uses a piezo-electric crystal to generate a wave form, in a reservoir containing a specific volume of fluid. Cavitation in fluid results in the generation of microscopic bubbles that implode upon the lens surface. The matrix of frequency, duration of ultrasound, and the control of temperature rise in the fluid medium leads to cleaning when a specific contact lens solution is present. The New Comfort device uses standard power (110 v/120 v). There is a four (4) foot cord and a UL approved wall transformer. The New Comfort device consists of the housing, lens baskets, a reservoir, electronics and a transducer. All components that come in contact with contact lenses or solutions are of medical grade composition and have been used in legally marketed predicate devices in the United States. The housing is injection molded of ABS. The baskets and supporting structure are injection molded from ABS. The reservoir is deep drawn stainless steel, is passivated and electropolished. The electronic circuitry has been used in other cleaning applications in other industries for years. The single crystal is affixed directly to the bottom of the reservoir with an epoxy generally used in cleaning applications in the ultrasound industry.
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    K Number
    K962112
    Device Name
    NEW COMFORT CONTACT LENS CARE ACCESSORY
    Manufacturer
    LENS COMFORT, INC.
    Date Cleared
    1996-11-29

    (182 days)

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

    LENS COMFORT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Lena Comfort Contact Lens Care Accessory is intended for use in conjunction with contact lens solutions as an accessory in the cleaning of contact lenses, Lens Comfort is Indicated as aid for cleaning as on accossory for soft hydrophilic lanses and gas permeable lenses when used with the appropriate Barnea-i hind® Soft Mate solutions auch as the Consept Cleaning and Disintection System which is comprised of the Bernes-Hinde Soft Mare Consept . 1 Cleaning and Disinfecting solution and Barnes-Hinde Soft Mate® Consepte-2 Neutralizing and Pinaing Solution or Spray. The Lans Comfort Contact Lons Care Accessory Is indicalad for use for gas permeable solutions auch as Barnes. Hind® Gas Permeable Daily Cleaner and Barnes-Hind® ComfortCare GP Welting and Solution. The Lens Comfort Contact Lons Care Accessory may be used for a receptacie for chamical disinfection.
    Device Description
    The Lens Comfort Ultrasonic Contact Lens Care Accessory uses a plezo-electric crystal to generate a wave form. In a reservoir containing a specific volume of fluid. Cavitation in fluid results in the generation of microscopic bubbles that implode upon the lens surface. The matrix of frequency, duration of ultrasound, and the control of tomperature rise in the fluid medium leads to cleaning when a specific contact lens solution is present. The Lans Comfort device uses standerd power (110 v/120 v). There is a four (4) foul cord and a UL approved wall transformer. The Lens Comfort device consists of the housing, lens beskets, a reasivoir, electronics and a transducer. All components that come in contact with contact lenses or solutions are of medical grade composition and have been used in legally merkated predicate devices in the United States. The housing is injection molded of polycarbonate. The baskets and supporting structure are injection molded from polyethylene. The reservoir is deep drawn stallnioss steel, is passivated and pollshed. The electronic circultry has been used in other cleaning applications in other industries for years. The single crystal is affixed directly to the bottom of the reservoir with an epoxy generally used in cleaning applications in the ultrasound industry.
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