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510(k) Data Aggregation

    K Number
    K142824
    Device Name
    LX-100 Hair Growth Stimulation System
    Date Cleared
    2015-04-14

    (196 days)

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

    Hairlabs International Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The LX-100 is a non-heating lamp as described under the provisions of 21 CFR §890.5500 and is indicated for: Adjunctive use for the treatment of androgenic alopecia in females; the LX-100 is indicated to promote hair growth of females with androgenetic alopecia who have Ludwig and Savin Hair Loss Scale classifications of I to II and who have been determined to have a Fitzpatrick Skin Typing of I to IV
    Device Description
    The LX-100 is a stationary low-level laser device that promotes hair growth and provides adjunctive treatment for androgenic (androgenetic) alopecia in females. The device provides automated and timed equal distribution of laser light to 100% of the scalp. The LX-100 operation is controlled by an operating system that affords the user maximum flexibility for individual treatments. The device applies a measured very high tolerance (≤+1%) wavelength (λ) to the scalp stimulating hair growth by the proven concept of biostimulation.
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