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    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    Intense Pulsed Light System

    K Number: K231394 · Decision Aug 9, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    92
    Registration Numbers
    93
    Same Product Code
    73
    Applicant Total
    5
    Review Days
    86

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    Basic Information

    Device Name
    Intense Pulsed Light System
    K Number
    K231394
    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
    Smedtrum Medical Technology Co., Ltd.
    Date Received
    May 15, 2023
    Decision Date
    August 9, 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 Smedtrum Medical Technology Co., Ltd.

    K Number Device Name
    K240482 Intense Pulsed Light System (ST-690)
    K240118 Picosecond Nd:YAG Laser System
    K230580 Diode Laser System
    K221597 CO2 Laser System