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510(k) Data Aggregation

    K Number
    K222477
    Device Name
    Hair Growth Device
    Manufacturer
    Dongguan Lescolton Medical Equipment Co., Ltd
    Date Cleared
    2022-11-18

    (94 days)

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

    Dongguan Lescolton Medical Equipment 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 IIa-V and females with androgenetic alopecia who have Ludwig-Savin Classifications of I-II and Fitzpatrick Classification of Skin Phototypes I to IV. All users should also have Fitzpatrick Skin Types I to IV.
    Device Description
    The Hair Growth Device LS-D620 is composed of 80 laser diodes (wavelength: 650-660nm, power<5mW) configured within an outer helmet and protective inner liner. The combined light is absorbed by the scalp. The use of diode lasers 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 designed to 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. The Hair Growth Device LS-D620 may produce 20% maximum output deviation in different treatment sites. The device uses a non detachable polymer lithium battery for power supply, and the continuous use time for the battery is 180 minutes. Which meets the requirements of IEC 62133-2 safety standard. The Hair Growth Device LS-D630 is composed of 162 laser diodes (wavelength: 650-660nm, power<5mW) configured within an outer helmet and protective inner liner. The combined light is absorbed by the scalp. The use of diode lasers 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 designed to 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. The Hair Growth Device LS-D630 may produce 20% maximum output deviation in different treatment sites. The device uses a non detachable polymer lithium battery for power supply, and the continuous use time for the battery is 80 minutes. Which meets the requirements of IEC 62133-2 safety standard.
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