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510(k) Data Aggregation

    K Number
    K021699
    Device Name
    AUTOLENS CLEANING AND DISINFECTING UNIT
    Manufacturer
    AUTOLENS INC.
    Date Cleared
    2002-12-16

    (208 days)

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

    AUTOLENS INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AUTOLENS ® Automatic Contact Lens Cleaning Accessory is indicated for the cleaning of soft (hydrophilic), rigid gas permeable (RGP) and hard (PMMA) contact lenses when used with AUTOLENS® Multipurpose Solution. This automatic contact lens cleaning accessory cleans contact lenses without digital rubbing. The AUTOLENS® Automatic Contact Lens Cleaning Accessory may be used as a receptacle for chemical disinfection with AUTOLENS® Multipurpose Solution. AUTOLENS® Multipurpose Solution is indicated for use in cleaning, rinsing, chemical (not heat) disinfecting and protein removal, storing soft (hydrophilic), rigid gas permeable (fluoro-silicone acrylate and silicone acrylate) and PMMA contact lenses as recommended by your eye care practitioner.
    Device Description
    The device is a holder, cleaning and disinfection system for contact lenses. It consists of a contact lens holder, bottle, cap and base. A separate battery operated tumbler device is integral to the system. It is designed to slowly tumble the bottle assembly including contact lens solution to effect cleaning of contact lenses. The lens holder is a single piece molded plastic device including hinged snap closure covers to contain each contact lens separately. An easily identifiable, raised letter "R" and "L" is included adjacent each closure receptacle to allow clear identification for right and left contact lenses placed within the lens holder. The lens holder contains openings to sufficiently allow the free flow of solution to circulate on all surfaces of the contact lens during the cleaning process. The bottle is made of molded plastic and is of oval shape to facilitate the flow of solution over the lens holder and lenses during operation. The bottle is of sufficient size to contain the lens holder and 8 ml. of contact lens solution to cover the contact lenses at all times during operation and storage. The bottle is designed to hold the contact lens holder securely to ensure its rotation as the bottle spins during operation. The bottle is designed with a fluid-tight, screw closure cap. The lens holder, bottle, cap and base are made of polypropylene resin plastic. The tumbler device is a battery powered unit operating at 1.5 volts utilizing three "AA" batteries. A plastic housing is molded to contain a small electrical motor, tumbler drive, on/off switch, batteries and a battery door to easily replace batteries. A cradle is molded within the shape of the housing to contain the assembled lens holder bottle. The drive shaft is connected to the motor inside the base housing. When the device is turned on at the switch, the battery operated electrical motor turns the extended drive shaft. The bottle assembly resting upon the drive shaft turns in unison. The mechanical action of the bottle assembly on the drive shaft provides for a rotation of approximately 10 RPM.
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