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510(k) Data Aggregation

    K Number
    K181734
    Device Name
    Beurer IPL 8500 device/ IPL VelvetSkin Pro
    Manufacturer
    Home Well Trading LTD
    Date Cleared
    2018-09-19

    (79 days)

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

    Home Well Trading LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The IPL 8500 device is an over-the-counter device intended for the removal of unwanted body and/or facial hair. IPL 8500 is also intended for permanent reduction in hair regrowth, defined as a long-term, stable reduction in the number of hairs regrowing when measured at 6. 9. and 12 months after the completion of treatment regimen.
    Device Description
    The Beurer IPL 8500 device is an intense pulse light hair reduction device. Phototherapy (Light-based) hair reduction is based on the theory of selective photothermolysis in which optical energy is used to disable hair re-growth. The Beurer IPL 8500 device is composed of a hand-held applicator and an external power supply/charger. The spot size (treatment area) in the Beurer IPL 8500 device is 4.5 cm² or 2 cm2 (for large and precise treatment windows, respectively). The device contains a lamp, a skin proximity and pigmentation sensor allowing application only on compatible skin tones and while in full contact with the treated area. If the Beurer IPL 8500 device is not properly applied (in full contact with the skin) or user skin tone is too dark/tanned, the device will provide indications on the faulty conditions and will not trigger a pulse.
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    K Number
    K181121
    Device Name
    Beurer IPL 5500 device/ IPL 5000/ IPL PureSkin Pro
    Manufacturer
    Home Well Trading LTD
    Date Cleared
    2018-06-28

    (59 days)

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

    Home Well Trading LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Beurer 5500 IPL Device is an over the counter device intended for the removal of unwanted body and/ or facial hair in adults. The Beurer 5500 IPL Device is also intended for permanent reduction in unwanted hair. Permanent hair reduction is defined as a long-term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of treatment regimen.
    Device Description
    The Beurer IPL 5500 device is pulsed light hair removal device. Light-based hair removal is based on the theory of selective photothermolysis in which optical energy is used to disable hair growth. The Beurer IPL 5500 device is composed of a hand held applicator and an external power supply. The spot size (treatment area) in the Beurer IPL 5500 device is 3 cm². The device contains a lamp, a skin proximity sensor and a skin pigmentation sensor to detect appropriate skin tones. If the Beurer IPL 5500 device is not properly applied (in full contact with the skin) or user skin tone is too dark/tanned, the Beurer IPL 5500 device will not trigger a pulse.
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