BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇫🇷 France

    INTEGRE LIO

    K Number: K251507 · Decision Feb 6, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    60
    Registration Numbers
    61
    Same Product Code
    179
    Applicant Total
    30
    Review Days
    266

    Basic Information

    Device Name
    INTEGRE LIO
    K Number
    K251507
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4390
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Quantel Medical
    Date Received
    May 16, 2025
    Decision Date
    February 6, 2026
    Product Code
    HQF
    Advisory Committee
    Ophthalmic
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HQF Laser, Ophthalmic

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