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510(k) Data Aggregation

    K Number
    K233224
    Device Name
    Epilaser Pro
    Manufacturer
    Epilady 2000 LLC
    Date Cleared
    2024-01-27

    (121 days)

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

    Epilady 2000 LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Epilaser Pro is an over-the-counter device intended for adjunctive use with shaving for hair removal sustained with periodic treatments. Epilaser is also intended for permanent reduction in hair regrowth (defined as a long-term, stable reduction in the number of hairs regrowing) when measured out to 6, 9, and 12 months after the completion of the treatment regimen.
    Device Description
    The Epilaser Pro is an over-the-counter, hand-held, hair removal device. It kills the root of the hair follicle using laser energy at 808 or 980nm. The system includes an algorithm that automatically targets individual hairs over the treatment area and the laser activates when it is pressed against the skin. A skin tone sensor ensures the correct skin tone prior to laser activation.
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    K Number
    K213105
    Device Name
    Epilaser Absolute
    Manufacturer
    Epilady 2000 LLC
    Date Cleared
    2022-12-13

    (445 days)

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

    Epilady 2000 LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Epilaser Absolute is an over-the-counter device intended for adjunctive use with shaving for hair removal sustained with periodic treatments. Epilaser is also intended for permanent reduction in hair regrowth defined as a long-term, stable reduction in hair counts following a treatment regime. Permanent hair reduction is defined as long term, stable reduction in the number of hairs regrowing when measured out to 6, 9, and 12 months after the completion of the treatment regimen.
    Device Description
    The Epilaser Absolute is an over-the-counter, hand-held, hair removal device. It kills the root of the hair follicle using laser energy at 808 or 980nm. The system is designed to be manually targeted onto individual hairs and the laser activates when it is pressed against the skin. A skin tone sensor ensures the user has the correct skin tone prior to laser activation.
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    K Number
    K170970
    Device Name
    Epilaser
    Manufacturer
    Epilady 2000 LLC
    Date Cleared
    2017-09-01

    (154 days)

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

    Epilady 2000 LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Epilaser is an over-the-counter device intended for adjunctive use with shaving for hair removal sustained with periodic treatments. Epilaser is also intended for permanent reduction in hair regrowth defined as a long-term, stable reduction in hair counts following a treatment regime. Permanent hair reduction is defined as long term, stable reduction in the number of hairs regrowing when measured out to 6, 9, and 12 months after the completion of the treatment regimen.
    Device Description
    The Epilaser is an over-the-counter, hand-held, hair removal device intended for hair removal on the face below the nose, underarms, and bikini line. It kills the root of the hair follicle using focused laser energy. The system has an integrated microscope and external viewing screen which allows the user to visualize and target individual hairs. The system is composed of a hand held laser containing multiple safety features and a dedicated viewing screen.
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