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510(k) Data Aggregation

    K Number
    K153081
    Device Name
    Clear Bi-Light
    Manufacturer
    Michael Todd, LP
    Date Cleared
    2016-02-15

    (115 days)

    Product Code
    OLP
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    Michael Todd, LP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Clear Bi-Light is indicated for the treatment of mild to moderate inflammatory acne.
    Device Description
    The Clear Bi-Light is a hand-held, light emitting device for treating mild to moderate acne. The Clear Bi-Light is non-prescription and is intended for over-the-counter sale. Each Clear Bi-Light package includes the following: - One Clear Bi-Light rechargeable handpiece - Two Treatment Heads - One blue light (405 - 420 nm) - One red light (630 660 nm) - One Charger Stand - One AC adaptor power cord - One pair goggles - The Clear Bi-Light Instruction Manual
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