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510(k) Data Aggregation

    K Number
    K101901
    Device Name
    IPL THERAPY SYSTEM
    Date Cleared
    2011-03-08

    (243 days)

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

    **BEIJING STARLIGHT SCIENCE **& TECHNOLOGY DEVELOPMENT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The IPL Therapy Systems (inclusive of the handpieces used to deliver pulsed-light energy) is indicated for use in surgical, aesthetic and cosmetic applications in the hair removal at a wavelength ranging from 640nm-1200nm.
    Device Description
    The IPL Therapy Systems (ST-AI) is an intense pulsed light system which delivers intense pulsed light at a wavelength ranging from 640nm-1200nm. Intense Pulsed Light (IPL) systems work on the principles of selective photothermolysis. 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 Therapy system is 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 IPL Therapy Systems (inclusive of the handpiece used to deliver pulsed-light energy) is indicated for use in surgical, aesthetic and cosmetic applications in the hair removal.
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