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510(k) Data Aggregation

    K Number
    K240611
    Device Name
    IVYLASER Diode laser hair removal system (IVY-HR-Alloy)
    Date Cleared
    2024-06-20

    (107 days)

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

    Ivylaser (Beijing) Technology Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Trio-Wavelength Handpiece combines 3 wavelengths (755+810+1064nm) into a single handpiece. It is intended for temporary hair reduction in Fast Hair Removal Mode(FHR).
    Device Description
    The Trio-Wavelength Handpiece combines 3 wavelengths (755+810+1064 nm) into a single handpiece, which intended for temporary hair reduction in Fast Hair Removal Mode(FHR). It consists of a main unit, a foot switch and a handle-piece. The foot switch and the handle switch are activated to start emitting light pulses. The hand-piece has a cooled light outlet. The laser parameters and other system functions are controlled by a control panel on the main unit.
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    K Number
    K230025
    Device Name
    IVYLASER Handhold Hair Removal Machine
    Date Cleared
    2023-07-03

    (180 days)

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

    Ivylaser (Beijing) Technology Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    IVYLASER Handhold Hair Removal Machine is an over-the-counter device intended for adjunctive use with shaving for hair removal sustained with periodic treatments. IVYLASER is also intended for permanent har reduction 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 is an over-the-counter device intended for adjunctive use with shaving for hair removal sustained with periodic treatments. It is also intended for permanent hair reduction Three models (iyoung mini-P, iyoung mini-GY, iyoung mini-GN) are included in IVYLASER Handhold Hair Removal Machine series products, and they have the same intended purposes and working theories.
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