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510(k) Data Aggregation

    K Number
    K173846
    Device Name
    DermaScalp Laser Cap
    Manufacturer
    DermaScalp LLC
    Date Cleared
    2018-03-21

    (92 days)

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

    DermaScalp LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The family of DermaScalp Laser Cap devices are indicated to treat Androgenetic Alpopecia and promote hair growth in Males who have Norwood Hamilton Classifications of IIa to V patterns of hair loss and to treat Androgenetic Alopecia and promote hair growth in Females who have Ludwig (Savin) Scale I-1 to I-4, II-2, or frontal; both with Fitzpatrick Skin Types I to IV.
    Device Description
    The family of DermaScalp Laser Cap devices are a hands-free, portable, non-invasive, low-level laser device intended to treat Androgenetic Alopecia (Hair Loss) and to promote hair growth in Males and Females. The DermaScalp Laser Cap devices provide distributed red laser light dispersing from a "Concave" scalp covering utilizing laser modules with a 650 nm wavelength, <5 mW output power, producing a continuous wave "CW" output beam. The "Concave" scalp covering is designed to maximize the delivery of the coherent laser light to effectively cover the entire scalp of the user during treatment.
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    K Number
    K152587
    Device Name
    DermaScalp Laser Cap
    Manufacturer
    DERMASCALP LLC
    Date Cleared
    2016-02-04

    (147 days)

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

    DERMASCALP LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DermaScalp Laser Cap is indicated to promote hair growth in females with Androgenetic Alpopecia who have Ludwig-Savin Classifications I-II and who have Fitzpatrick Skin Types I to IV.
    Device Description
    The DermaScalp MD Laser Cap and the DermaScalp MDX Laser Cap devices are a hands-free, portable, non-invasive, low-level laser device intended to treat Androgenetic Alopecia (Hair Loss) and to promote hair growth in Females. The DermaScalp Laser Cap devices provide distributed red laser light dispersing from a "Concave" scalp covering utilizing laser modules with a 650 nm wavelength, <5 mW output power, producing a continuous wave "CW" output beam. The "Concave" scalp covering is designed to maximize the delivery of the coherent laser light to effectively cover the entire scalp of the user during treatment.
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