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

    Intensity Pulsed Light Therapy System

    K Number: K233307 · Decision Mar 15, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    92
    Registration Numbers
    93
    Same Product Code
    73
    Applicant Total
    10
    Review Days
    168

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    Basic Information

    Device Name
    Intensity Pulsed Light Therapy System
    K Number
    K233307
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4810
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Beijing Adss Development Co., Ltd.
    Date Received
    September 29, 2023
    Decision Date
    March 15, 2024
    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 Beijing Adss Development Co., Ltd.

    K Number Device Name
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    K231318 Electromagnetic Stimulator Device(Model EM Contouring and Tesla Duet)
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    K192295 PDT-FACE
    K161926 ND YAG Q-switch Laser Therapy Machine
    K161692 Diode Laser Therapy Machine
    K161925 CO2 Laser Therapy Machine
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