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510(k) Data Aggregation

    K Number
    K171895
    Device Name
    Grivamax Hair Growth System
    Manufacturer
    Leana Orders, Inc.
    Date Cleared
    2017-08-22

    (57 days)

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

    Leana Orders, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Grivamax Hair Growth System is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications of I - II, males who have Norwood-Hamilton Classifications of IIa – V and for both, Fitzpatrick Classification of Skin Phototypes I to IV.
    Device Description
    The Grivamax Hair Growth System consists of 272 diode lasers configured within an outer cap helmet and protective inner liner. 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 Grivamax Hair Growth System is powered by a lithium-ion battery pack that contains an embedded controller chip.
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