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510(k) Data Aggregation

    K Number
    K241916
    Device Name
    TearRepair Liquid Skin Protectant
    Manufacturer
    OptMed, Inc.
    Date Cleared
    2024-09-27

    (88 days)

    Product Code
    KMF
    Regulation Number
    880.5090
    Why did this record match?
    Applicant Name (Manufacturer) :

    OptMed, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TearRepair is intended to be used in areas exposed to mechanical forces such as friction and shear from bedding, olothing. shoes, or any material that may damage the skin. TearRepair can also be used to irritation from moisture such as urine, feces, digestive juices, perspiration, and wound drainage. TearRepair can also help protect the skin against irritation caused by adhesive products.
    Device Description
    TearRepair Liguid Skin Protectant is a rapid-drying liquid barrier film for the protection of the skin. It is applied as a liquid and dries within minutes, adhering to the contours of the skin to form a transparent flexible film. TearRepair will wear off, naturally, and is provided as a singleuse, sterile device provided as Rx Only.
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    K Number
    K141157
    Device Name
    BONDEASE TOPICAL SKIN ADHESIVE
    Manufacturer
    OPTMED, INC.
    Date Cleared
    2015-12-22

    (596 days)

    Product Code
    MPN
    Regulation Number
    878.4010
    Why did this record match?
    Applicant Name (Manufacturer) :

    OPTMED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BondEase® Topical Skin Adhesive is intended for topical use only, to hold together the skin edges of incisions and lacerations that are under minimal tension and easily approximated. Where significant tension exists on incisions or lacerations, BondEase® Topical Skin Adhesive should be used in conjunction with deep dermal stiches.
    Device Description
    BondEase® Topical Skin Adhesive is a sterile, liquid topical skin closure device composed of a methylidene malonate monomer formulation and the colorant D&C Green #6. It is provided in a single-use applicator, packaged in a foil pouch. The applicator is comprised of a crushable glass ampoule contained within a plastic vial with attached applicator tip and handle. BondEase® is applied to the skin as a viscous liquid which polymerizes to bond approximated wound edges within minutes. In vitro studies have shown that BondEase® acts as a bacterial barrier as long as the adhesive film remains intact.
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