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510(k) Data Aggregation

    K Number
    K161776
    Device Name
    Lenstec LC Injection system
    Manufacturer
    LENSTEC INC.
    Date Cleared
    2016-11-29

    (153 days)

    Product Code
    MSS
    Regulation Number
    886.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    LENSTEC INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Lenstec's LC Injection System is intended for use in the implantation of the Softec I, Softec HDO, Softec HDM and any approved IOL in which labeling specifies use of this injector (s) to insert the capsular bag following extracapsular extraction.
    Device Description
    The proposed system consists of the following components: Cartridge with silicone cushion, IOL, and Injector. Three types of injectors are provided: they are syringe based and reusable and autoclavable. One type of lens loader is provided, which is reusable and autoclavable. The cartridges/silicone cushion are single-use and are provided sterile.
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