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

    LED Light Therapy Mask (SKB-1818P,SKB-1918,SKB-1918P,SKB-1918PLUS,SKB-2318L,SKB-2318P,SKB-2318PRO,IN-FM002, SKB-2418)

    K Number: K243040 · Decision Dec 20, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    126
    Registration Numbers
    126
    Same Product Code
    152
    Applicant Total
    6
    Review Days
    84

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    Basic Information

    Device Name
    LED Light Therapy Mask (SKB-1818P,SKB-1918,SKB-1918P,SKB-1918PLUS,SKB-2318L,SKB-2318P,SKB-2318PRO,IN-FM002, SKB-2418)
    K Number
    K243040
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4810
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shenzhen Siken 3D Technology Development Co., Ltd.
    Date Received
    September 27, 2024
    Decision Date
    December 20, 2024
    Product Code
    OHS
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    OHS Light Based Over The Counter Wrinkle Reduction

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