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510(k) Data Aggregation

    K Number
    K222364
    Device Name
    Xtrallux Alpha (XA136R-USA), Xtrallux Super Plus (XS276R-USA/XS276L-USA), Xtrallux Turbo Pro (XP316R-USA), Xtrallux Extreme RX (XR352R-USA)
    Manufacturer
    Date Cleared
    2022-11-16

    (104 days)

    Product Code
    Regulation Number
    890.5500
    Why did this record match?
    Applicant Name (Manufacturer) :

    Xtrallux, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Xtrallux Alpha, Super Plus, Turbo Pro, and Extreme RX are intended to treat Androgenetic Alopecia (AGA) and promote hair growth in males who have Norwood-Hamilton Classifications of hair loss and, females who have Ludwig (Savin) Scale I-1 to I-4, II-1, II-2, or frontal; both with Fitzpatrick Skin Types I to IV.
    Device Description
    The Xtrallux devices are non-invasive, low level laser therapy (LLT) devices containing red, visible light diode lasers operating at 650 nm wavelength. The maximum power output of each diode is 5 mW. The diodes are configured within a cap, enclosed between the outer shell and inner liner. They deliver non-thermal energy to hair follicles via photostimulation of the scalp and are intended to stimulate hair growth. Xtrallux has developed four models: Xtrallux Alpha, Xtrallux Super Plus, Xtrallux Turbo Pro, Xtrallux Extreme RX.
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