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510(k) Data Aggregation

    K Number
    K252732
    Date Cleared
    2025-10-23

    (56 days)

    Product Code
    Regulation Number
    878.4810
    Reference & Predicate Devices
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K182173

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    1927nm Thulium Laser System is indicated for use in dermatological procedures requiring coagulation of soft tissue, treatment of actinic keratosis and treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots) and ephelides (freckles).

    Device Description

    1927nm Thulium Laser System contains a thulium-doped fiber laser module that uses a 1927nm pulsed laser output energy. The beam is directly irradiated to the treatment area through the handle and optical fiber. According to the selective light absorption theory, the1927nm laser can be preferentially absorbed by the water in the skin, thus achieving the purpose of coagulation of soft tissue.

    The operator can optimize the treatment effect of each application by controlling the pulse width, distance between the dot matrices and treatment mode of the pulsed laser.

    There are 2 models included, PZ-DJG75-01, PZ-DJG75-02, the two models have the same intended use, mechanism of action and principle, only the step of pulse width under the dot matrix mode are different. The detailed differences shown as following:

    Table 1 The differences between two models

    ModelWavelengthModePulse width (±20%)Step
    PZ-DJG75-011927nm±10nmSlide0.2-2.0ms0.1ms
    Dot matrix0.2-20.0ms0.1ms
    PZ-DJG75-021927nm±10nmSlide0.2-2.0ms0.1ms
    Dot matrix0.2-20.0ms0.2ms
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