BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Assisted Reproduction Laser System (Model ILS-400M)

    K Number: K253333 · Decision Jun 17, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    10
    Applicant Total
    2
    Review Days
    260

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    Basic Information

    Device Name
    Assisted Reproduction Laser System (Model ILS-400M)
    K Number
    K253333
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.6200
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hua Yue Medical Technology Co., Ltd.
    Date Received
    September 30, 2025
    Decision Date
    June 17, 2026
    Product Code
    MRX
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

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

    Product Code Device Name
    MRX System, Assisted Reproduction Laser

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