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510(k) Data Aggregation

    K Number
    K240857
    Device Name
    Youmagic FLM System (YM5-U1)
    Date Cleared
    2025-05-15

    (413 days)

    Product Code
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    WE Medical Technology (Wuxi) Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The radiofrequency-energy only delivery components of the Youmagic FLM System are indicated for use in dermatologic surgical procedures for electrocoagulation and hemostasis. The Youmagic FLM System is a prescription use device.
    Device Description
    The Youmagic FLM System delivers RF energy for selective coagulation of tissue while conductively cooling the epidermis. The Youmagic FLM System delivers energy from the disposable tip to the patient. The System and its Handpiece monitor skin contact during treatment. The System employs RF tuning to provide RF energy across a range of impedances for delivery to the patient through single and multiple pass stamping motions of the tip. The Youmagic FLM System is a monopolar, conductive radiofrequency System designed for use in non-invasive dermatological procedures. The System consists of the following components: Console, including touchscreen, a Handpiece, Treatment Tip, and AC power cord. The System is used with the following WE Medical-supplied accessories: Cryogen Canister, Return Pad. The System continuously monitors output power, output energy, treatment duration, and measured impedance. The System also controls the coolant delivery through the Handpiece. The Handpiece delivers RF energy while cooling tissue by thermal conduction.
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