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510(k) Data Aggregation

    K Number
    K193667
    Device Name
    Shapiro MD model laser 272
    Manufacturer
    Conversion Labs, PR, LLC
    Date Cleared
    2020-03-25

    (85 days)

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

    Conversion Labs, PR, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Shapiro MD, Model Laser 272 is indicated to promote hair growth in males with androgenic alopecia who have Norwood-Hamilton Classifications of IIa - V, or females with androgenic alopecia who have Ludwig-Savin Classifications I - II, and for both, with Fitzpatrick Skin Phototypes I- IV.
    Device Description
    The Shapiro MD, Model Laser 272 is a dome-shaped low level laser therapy (LLLT) device designed to promote hair growth in women and men by exposing the entire scalp to the photobiostimulation of 272 visible red light-emitting diodes at 650mm and 5mW each. The Cap is designed with an outer plastic cover and a protective inner (containing the electronics and laser array) and is powered by an included battery pack.
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