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510(k) Data Aggregation

    K Number
    K241229
    Device Name
    Hello,eyes® BIO Plug
    Manufacturer
    Bio Optics Co., Ltd.
    Date Cleared
    2024-06-28

    (57 days)

    Product Code
    LZU
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    Bio Optics Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Hello,eyes® BIO Plug is intended to temporarily block tear drainage by the occlusion of the canaliculus in order to - Temporarily treat dry eye syndrome, and the dry eye components of various ocular surface diseases, - Temporarily enhance the efficacy of topical medications or ocular lubricants, - Temporarily treat contact lens intolerance secondary to dry eye, - Temporarily treat dry eye after ocular surgery, and. - Determine the potential effectiveness of permanent occlusion.
    Device Description
    Intracanalicular Plug named Hello,eyes@BIO Plug consists of lacrimal punctum plug and its holder. The plug is made of polydioxanone per 21 CFR 878.4840. The pigment for the violet dye is D&C Violet No.2 per 21 CFR 74.3602. It is 2.0mm long and available in three diameters: 0.3, 0.4, and 0.5mm which are based on USP synthetic absorbable suture diameters. Hello, eyes@ BIO Plug, the intracanalicular plug is a product sterile by ethylene oxide (EO) gas in accordance with ISO 11135:2014. It is designed to be inserted through the punctal opening and reside in the canaliculus until it is absorbed over time in tissue.
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