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

    Diode Laser Therapy System

    K Number: K231896 · Decision Feb 20, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    478
    Registration Numbers
    480
    Same Product Code
    2867
    Applicant Total
    10
    Review Days
    237

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    Basic Information

    Device Name
    Diode Laser Therapy System
    K Number
    K231896
    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
    Beijing Adss Development Co., Ltd.
    Date Received
    June 28, 2023
    Decision Date
    February 20, 2024
    Product Code
    GEX
    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
    GEX Powered Laser Surgical Instrument

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    Other Clearances by Beijing Adss Development Co., Ltd.

    K Number Device Name
    K241670 Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System (FG900-S2)
    K233307 Intensity Pulsed Light Therapy System
    K231318 Electromagnetic Stimulator Device(Model EM Contouring and Tesla Duet)
    K220268 Picosecond Laser System (Model PS10-A and PS10-B)
    K192295 PDT-FACE
    K161926 ND YAG Q-switch Laser Therapy Machine
    K161692 Diode Laser Therapy Machine
    K161925 CO2 Laser Therapy Machine
    K161286 IPL Therapy Machine