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510(k) Data Aggregation

    K Number
    K202038
    Device Name
    CryoTreQ
    Manufacturer
    VitreQ B.V.
    Date Cleared
    2020-12-30

    (160 days)

    Product Code
    HPS, CLA
    Regulation Number
    886.4170
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    Product Code :

    HPS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VitreQ CryoTreQ is indicated for use in ophthalmic surgery for retinal detachment, cyclodestructive procedures in refractory glaucoma, extraction of fragments within the vitreous cavity, cataract extraction, cryodestruction of lash follicles for trichiasis and the treatment of retinopathy of prematurity (ROP).
    Device Description
    The VitreQ CryoTreQ is a disposable, handheld instrument intended for use in ophthalmic cryotherapy. The device tip is made of stainless steel. The device utilizes a pressurized cryogen which is circulated to the tip. The cryogenic material remains enclosed within the tip during application, serving to cool the metal tip during therapy. Rapid gas expansion in the tip causes freezing to the Joule-Thompson principle.
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