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510(k) Data Aggregation

    K Number
    K120886
    Device Name
    LACRIFAST
    Manufacturer
    HIROYASU HIGUCHI
    Date Cleared
    2012-12-17

    (269 days)

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

    HIROYASU HIGUCHI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LACRIFLOW is indicated in treatments of epiphora in patients 12 months and older, in cases of: - Canalicular pathologies (stenosis, obstruction, lacerations), - During Dacryocystorhinostomy (conventional or laser), - Congenital nasolacrimal duct obstruction.
    Device Description
    The LACRIFLOW is intended for the treatment of epiphora due to conditions including the obstructions of lacrimal punctum, lacrimal canaliculus, or nasolacrimal duct. The LACRIFLOW consists of the Lacrimal duct tube and the Bougie. The Lacrimal duct tube is intended to be inserted and placed inside the lacrimal canaliculus or other sites to dilate the lacrimal duct, and the Bougie is intended to be used for the insertion of the Lacrimal duct tube and removed after insertion of Lacrimal duct tube. Lacrimal duct is dilated by insertion of the Lacrimal duct tube into the obstructed site.
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