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510(k) Data Aggregation

    K Number
    K163173
    Device Name
    Handheld Diode Laser for Hair Removal
    Date Cleared
    2017-02-08

    (86 days)

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

    Liaoning Sidey Optoelectronics Technologies Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Handheld Diode Laser for Hair Removal is an over-the-counter device intended for adjunctive use with shaving for hair removal sustained with periodic treatments. Handheld Diode Laser for Hair Removal is also intended for permanent reduction in hair regrowth defined as a long-term, stable reduction in hair counts following a treatment regime. permanent hair reduction is defined as long term, stable reduction in the number of hairs regrowing when measured out to 6, 9, and 12 months after the completion of the treatment regimen.
    Device Description
    The Handheld Diode Laser for Hair Removal is an Over-The-Counter device intended for adjunctive use with shaving for hair removal sustained with periodic treatments. The device is also intended for permanent reduction in hair regrowth defined as a long-term, stable reduction in hair counts following a treatment regime permanent hair reduction is defined as long term, stale reduction in the number of hairs regrowing when measured out of 6, 9, and 12 months after the completion of the treatment regimen. The Handheld Diode Laser for Hair Removal is a semiconductor diode laser system that delivers infrared light at a wavelength of nominally 808nm. Laser hair removal is based on the principles of selective photothermolysis (SPTL): a combination of the appropriate laser wavelength, pulse duration, and fluence can obtain optimal effect on a targeted tissue with minimal effect on surrounding tissue. Wavelengths of 808 nanometers (nm) are widely used in hair removal treatment, it is selectively absorbed by melanin in the hair shaft, damaging the follicular epithelium, and further causes hair loss, while the competing chromophores (oxyhemoglobin and water) absorb less energy at these wavelengths.
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