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510(k) Data Aggregation

    K Number
    K243990
    Device Name
    BondEase 2 Topical Skin Adhesive
    Manufacturer
    OptMed, Inc.
    Date Cleared
    2025-09-19

    (267 days)

    Product Code
    MPN
    Regulation Number
    878.4010
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K241916,K152096,K141157
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    BondEase® 2 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® 2 Topical Skin Adhesive should be used in conjunction with deep dermal stitches.

    Device Description

    BondEase 2 Topical Skin Adhesive is a sterile, liquid topical skin closure device composed of a methylidene malonate monomer formulation. The adhesive is composed of two solutions which must be mixed to polymerize: the methylidene malonate monomer solution (Part A) and the polymerization activator solution (Part B). BondEase 2 is provided as a single-use applicator, packaged in a foil pouch. The applicator comprises a plastic tube containing a crushable glass ampoule, a porous filter, and a tip subassembly, which is inserted into a plastic handle.

    AI/ML Overview

    N/A

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