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510(k) Data Aggregation

    K Number
    K232356
    Device Name
    Laser Cap, Model: Hat-01
    Manufacturer
    Hubei YJT Technology Co.,Ltd
    Date Cleared
    2023-10-24

    (78 days)

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

    Hubei YJT Technology Co.,Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Laser Cap is indicated to promote hair growth in males with androgenic alopecia who have Norwood-Hamilton classifications of IIa-V or females with androgenic alopecia who have Ludwig-Savin Classifications of I-II and both with Skin Phototypes I-IV.
    Device Description
    Laser Cap is a hand-held cap-shaped low level laser therapy device that emits laser light designed to promote hair growth in women and men. The device provides distributed laser light to the scalp while the cap covers the user's scalp to ensure the laser light reaches the user's scalp. Model Hat-01 contains 82 laser diodes.
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    K Number
    K230134
    Device Name
    Laser Therapy Hair Growth Comb, Model: Lasercomb-001 & Lasercomb-002
    Manufacturer
    Hubei YJT Technology Co.,Ltd
    Date Cleared
    2023-05-23

    (126 days)

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

    Hubei YJT Technology Co.,Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Laser Therapy Hair Growth Comb is indicated to treat Androgenetic Alopecia, and promote hair growth in females who have Ludwig (Savin) I-4, II-1, II-2, or frontal patterns of hair loss and in males who have Norwood Hamilton Classifications of IIa to V and who both have Fitzpatrick Skin Types I to IV.
    Device Description
    Laser Therapy Hair Growth Comb is a hand-held comb-shaped low level laser therapy device that emits laser light designed to promote hair growth in women and men. The device provides distributed laser light to the scalp while the comb teeth simultaneously part the user's hair to ensure the laser light reaches the user's scalp. Lasercomb-001 contains 7 laser diodes, and Lasercomb-002 contains 9 laser diodes.
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