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510(k) Data Aggregation

    K Number
    K242620
    Device Name
    Breo Laser Hair Growth Comb (Scalp 3L)
    Manufacturer
    Shenzhen Breo Technology Co., Ltd.
    Date Cleared
    2024-11-01

    (59 days)

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

    Shenzhen Breo Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Breo Laser Hair Growth Comb is indicated to treat Androgenetic Aloperia, and promote hair growth in females who have Ludwig (Savin) 1-4, 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
    Breo Laser 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. The device also has a massage function which is a mechanical vibration function.
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