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

    Bosley Revitalizer 96 Laser Cap, Bosley Revitalizer 96 XL Laser Cap

    K Number: K192585 · Decision Jan 29, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    67
    Registration Numbers
    67
    Same Product Code
    109
    Applicant Total
    2
    Review Days
    132

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    Basic Information

    Device Name
    Bosley Revitalizer 96 Laser Cap, Bosley Revitalizer 96 XL Laser Cap
    K Number
    K192585
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    890.5500
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pjm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC
    Date Received
    September 19, 2019
    Decision Date
    January 29, 2020
    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 Pjm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC

    K Number Device Name
    K181253 Bosley Revitalizer 272 Laser Cap, Bosley Revitalizer 164 Laser Cup