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

    Intense Pulsed Light Treatment System

    K Number: K230816 · Decision Apr 21, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    92
    Registration Numbers
    93
    Same Product Code
    73
    Applicant Total
    5
    Review Days
    28

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    Basic Information

    Device Name
    Intense Pulsed Light Treatment System
    K Number
    K230816
    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
    Shangdong Huamei Technology Co., Ltd.
    Date Received
    March 24, 2023
    Decision Date
    April 21, 2023
    Product Code
    ONF
    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
    ONF Powered Light Based Non-Laser Surgical Instrument With Thermal Effect

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    Other Clearances by Shangdong Huamei Technology Co., Ltd.

    K Number Device Name
    K202758 Nd: YAG Laser Therapy Systems HM-YL900
    K200751 Photodynamic Therapy (PDT) Equipment
    K192521 Intense Pulsed Light Treatment System
    K192528 CO2 Laser Therapy System