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510(k) Data Aggregation

    K Number
    K213447
    Device Name
    LLLT Laser Hair Growth Cap, Model: Hair Care 88, Hair Care 135, Hair Care 210.
    Manufacturer
    Shenzhen CosBeauty Technology Co., Ltd.
    Date Cleared
    2022-01-19

    (86 days)

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

    Shenzhen CosBeauty Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    LLLT Laser Hair Growth Cap is indicated to promote hair growth in males with androgenic alopecia who have Norwood-Hamilton classifications of Ila-V or females with androgenic alopecia who have Ludwig-Savin Classifications of I-II and both with Fitzpatrick Skin Phototypes I-IV.
    Device Description
    LLLT Laser Hair Growth Cap is a dome-shaped low level laser therapy (LLLT) device designed to promote hair growth in women and men by exposing the entire scalp to the photobiostimulation of visible red light-emitting diodes at 650mm and 5mW each. LLLT Laser Hair Growth Cap includes three models, Hair Care 210, Hair Care 135 and Hair Care 210 (210 diodes) is the typical model, Hair Care 135 (135 diodes) and Hair Care 88 (88 diodes) are exactly the same as the Hair Care 210 regarding structure design, intended use, performance and operation, with the difference being the diode amount. Each model has three colors, which are white, hidden color and pool blue.
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