BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇰🇷 South Korea

    Diamond Air+ (UI04A, UI04B, UI04C)

    K Number: K221553 · Decision Sep 15, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    90
    Registration Numbers
    91
    Same Product Code
    161
    Applicant Total
    3
    Review Days
    107

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    Basic Information

    Device Name
    Diamond Air+ (UI04A, UI04B, UI04C)
    K Number
    K221553
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.4810
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ulike Co., Ltd.
    Date Received
    May 31, 2022
    Decision Date
    September 15, 2022
    Product Code
    OHT
    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
    OHT Light Based Over-The-Counter Hair Removal

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    Other Clearances by Ulike Co., Ltd.

    K Number Device Name
    K243030 Diamond Air+ (UI04A, UI04B, UI04C, UI04M, UI04G, UI04W)
    K213558 IPL Hair Removal Device