BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Grivamax Hair Growth System

    K Number: K171895 · Decision Aug 22, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    67
    Registration Numbers
    67
    Same Product Code
    109
    Applicant Total
    2
    Review Days
    57

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    Basic Information

    Device Name
    Grivamax Hair Growth System
    K Number
    K171895
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5500
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Leana Orders, Inc.
    Date Received
    June 26, 2017
    Decision Date
    August 22, 2017
    Product Code
    OAP
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    OAP Laser, Comb, Hair

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    Other Clearances by Leana Orders, Inc.

    K Number Device Name
    K211192 Grivamax Family of Lasers, Models 272 and 148