Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K202257
    Device Name
    Dermatological Diode Laser Systems
    Date Cleared
    2021-04-23

    (256 days)

    Product Code
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    Zhuolu Jontelaser Manufacturing Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Dermatological Diode Laser Systems is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
    Device Description
    The proposed device, Diode Laser Therapy System, is a surgical device, which is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI); There are 2 models included, T5 Pro and T8 Pro, the two models have same intended use, mechanism of action, principle and specification, only difference is the configuration. The main components of proposed device shown as following: Handpiece, Touchscreen, Emergency Switch, Key Switch, Connector, Indicator Lamp, Foot Switch.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1