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

    Aimanfun Lumea Comfort, Model: A-2788, A-2789 and A-3588

    K Number: K230107 · Decision Apr 5, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    90
    Registration Numbers
    91
    Same Product Code
    161
    Applicant Total
    5
    Review Days
    82

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    Basic Information

    Device Name
    Aimanfun Lumea Comfort, Model: A-2788, A-2789 and A-3588
    K Number
    K230107
    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
    Kam Yuen Plastic Products , Ltd.
    Date Received
    January 13, 2023
    Decision Date
    April 5, 2023
    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 Kam Yuen Plastic Products , Ltd.

    K Number Device Name
    K213027 Laser Hair Growth Comb
    K213025 Laser hair growth helmet
    K212907 Aimanfun Lumea Comfort, A-2789/A-3588
    K190820 Aimanfun Lumea Comfort