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    K Number
    K191754
    Device Name
    Hair Growth System
    Manufacturer
    Kunshan Bella Optical technology Co., Ltd.
    Date Cleared
    2019-11-22

    (144 days)

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

    Kunshan Bella Optical technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Hair Growth System, Models: SPARK-3 and SPARK-4 are indicated to promote hair growth in females with androgenetic alopecia who have Ludwing -Savin Classifications of I-II, in males with androgenetic alopecia who have Norwood -Hamilton Classifications of IIa - V and for both, Fitzpatrick Classification of Skin Phototypes I to IV.
    Device Description
    Not Found
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