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510(k) Data Aggregation

    K Number
    K210169
    Device Name
    Hair Growth Device
    Manufacturer
    Dongguan Lescolton Intelligent Electrical Appliance Co., Ltd
    Date Cleared
    2021-04-16

    (84 days)

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

    Dongguan Lescolton Intelligent Electrical Appliance Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Hair Growth Device is indicated to promote hair growth in males with androgenetic alopecia who have Hamilton-Norwood Classifications of Ila-V and females with androgenetic alopecia who have Ludwig-Savin Classifications of I-II and Fitzpatrick Classification of Skin Phototypes I to IV.
    Device Description
    The Hair Growth Device LS-D601 is composed of 26 3R class laser diodes (wavelength: 650-660nm, power<5mW) and 30 red light diodes (wavelength: 640nm-660mm) configured within an outer helmet and protective inner liner. The use of diode lasers and non-laser LEDs provides for a full coverage of the upper 1/3 of the head; i.e., the area commonly covered with stylized hair. The helmet system will automatically pause to therapy if the subject's head is moved outside of the zone of radiation and will resume therapy when the correct head position is re-established. At the end of the therapy cycle, the system signals that therapy is complete and ready to be powered down, by emitting an audible beep pattern.
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