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510(k) Data Aggregation

    K Number
    K232708
    Device Name
    Intense pulsed light therapy device
    Manufacturer
    Hebei Zhemai Technology Co.,Ltd
    Date Cleared
    2023-12-01

    (87 days)

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

    Hebei Zhemai Technology Co.,Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Intense pulsed light therapy device is indicated for use in surgical and aesthetic applications in permanent hair removal. 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 regimen.
    Device Description
    The Intense pulsed light therapy device is an intense pulsed light system which delivers intense pulsed light at a wavelength ranging from 650-1200nm. Intense Pulsed Light (IPL) systems work on the principles of selective thermolysis. That is, causing thermal damage to target chromophores by using light of appropriate wavelength in pulses that exceeds the chromophores' thermal relaxation time but sparing normal skin by limiting the pulse width below the thermal relaxation time for skin. IPL Systems are different from lasers in that they deliver many wavelengths in each pulse of light instead of just one wavelength. Generally, IPL enhances penetration without using excessive energy levels and enables targeting of specific chromophores. Based on this, the Intense pulsed light therapy device is indicated for use in surgical and aesthetic applications in permanent hair removal.
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