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510(k) Data Aggregation

    K Number
    K192585
    Device Name
    Bosley Revitalizer 96 Laser Cap, Bosley Revitalizer 96 XL Laser Cap
    Manufacturer
    PJM Worldwide, LLC d/b/a Phoenix Medical Technology, LLC
    Date Cleared
    2020-01-29

    (132 days)

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

    PJM Worldwide, LLC d/b/a Phoenix Medical Technology, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Bosley Revitalizer 96 Laser Cap is indicated to treat Androgenic Alopecia and promote hair growth in males who have Norwood-Hamilton Classifications of Ila to V patterns of hair loss and to treat Androgenic Alopecia and promote hair growth in females who have Ludwig (Savin) Scale I-1 to I-4, II-1, II-2, or frontal; both with Fitzpatrick Skin Types I to IV.
    Device Description
    The Bosley Revitalizer 96 Laser Cap consists of 96 red, visible light, diode lasers operating at 650 nanometers, configured within an outer helmet and protective inner liner, and configured for portable use with rechargeable battery and adapter. Just as with the Bosley Revitalizer 272 and 164 Laser Caps, the 96 Laser Cap system can detect whether or not the device is in the correct position on the user's head and will automatically pause therapy if it is not. The device will resume therapy when the correct head position is re-established. The system is powered by rechargeable Lithium-ion battery cells assembled into a proprietary battery pack. Both the battery pack and charger are fully compliant with recognized, international standards.
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    K Number
    K181253
    Device Name
    Bosley Revitalizer 272 Laser Cap, Bosley Revitalizer 164 Laser Cup
    Manufacturer
    PJM Worldwide, LLC d/b/a Phoenix Medical Technology, LLC
    Date Cleared
    2018-08-10

    (91 days)

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

    PJM Worldwide, LLC d/b/a Phoenix Medical Technology, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BOSLEY Revitalizer 272 and 164 Laser Caps are indicated to treat Androgenic Alopecia and promote hair growth in males who have Norwood-Hamilton Classifications of Ila to V patterns of hair loss and to treat Androgenic Alopecia and promote hair growth in females who have Ludwig (Savin) Scale I-1 to I-4, II-1, II-3, or frontal; both with Fitzpatrick Skin Types I to IV.
    Device Description
    The BOSLEY Revitalizer 272 and 164 Laser Caps are low level laser therapy (LLLT) devices designed to promote hair growth in women and men by exposing the entire scalp to the photobiostimulation of 272 or 164 visible red light-emitting diodes at 650-nm and 5mW each. The lasers are contained inside a lightweight cap. The device is powered by an included battery pack and automatically turns off after 30 minutes.
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