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510(k) Data Aggregation

    K Number
    K992630
    Device Name
    THERMALIGHT 2000
    Manufacturer
    Date Cleared
    1999-09-10

    (87 days)

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

    JENNIFERMAXX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The THERMALIGHT®® 2000 is indicated for removal of unwanted body hair through the application of pulsed light energy applied to the hair follicle at the surface of the skin (non-invasive photo-epilation).
    Device Description
    The Thermalight2000 is an instrument which is designed to painlessly, safely, and effectively remove hair by the application of pulsed light energy to the hair follicle. It operates similar to needle electrolysis machine in that it removes hair, one hair at a time by thermolysis. Using the Thermalight2000, thermolysis is achieved by the application of light energy to the hair growth support tissue instead of the application of electrical energy employed by conventional needle electrolysis units.
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