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510(k) Data Aggregation

    K Number
    K141181
    Device Name
    NUVE FOR WRINKLES, DPL NUVE FOR WRINKLES
    Manufacturer
    LED TECHNOLOGIES, LLC
    Date Cleared
    2015-03-31

    (328 days)

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

    LED TECHNOLOGIES, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Nive for Wrinkles is an Over-the-Counter (OTC) device intended for the use in treating full-face wrinkles.
    Device Description
    The Nüve for Wrinkles is an over-the-counter hand-held light emitting diode (LED) device that emits energy for use in dermatology for the treatment of wrinkles and fine lines. The device uses four types of LEDs : 605nm amber, 630nm red, 660nm red, and 880nm infrared. The treatment time is controlled by the user. There are no user settings or adiustments required. The Nuve for Wrinkles system components include the handheld unit containing the LED module , power supply, goggles, and travel case. The unit is applied directly to the skin to ensure consistent administration of light during each treatment. The device does not contain any user serviceable components. The device is sold as Over the Counter (OTC).
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    K Number
    K101382
    Device Name
    DPL NUVE
    Manufacturer
    LED TECHNOLOGIES, LLC
    Date Cleared
    2010-11-09

    (176 days)

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

    LED TECHNOLOGIES, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intended to emit energy in the red and infrared region of the spectrum for use in dermatology for the treatment of periorbital wrinkles. Indicated as an over-the-counter phototherapy device for the treatment of mild to moderate acne.
    Device Description
    The dpl® Nüve is a lightweight, handheld, light emitting diode (LED) device with interchangeable heads which emit light energy. A blue LED head in the 415 nm spectrum is used in treatment for mild to moderate inflammatory acne. A red head at 625 nm and a purple head (infrared) in the 830 nm spectrum are used in combination for reduction of periorbital wrinkles. The handle of the device contains the electronics of the device including a fan for cooling and an automatic shut-off safety feature
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    K Number
    K081570
    Device Name
    DPL THERAPY SYSTEM
    Manufacturer
    LED TECHNOLOGIES, LLC
    Date Cleared
    2008-11-07

    (156 days)

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

    LED TECHNOLOGIES, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intended for the relaxation of muscles and relief of muscle spasms; temporary relief of minor muscle and joint aches, pains, and stiffness; temporary relief of minor pain and stiffness associated with arthritis; and to temporarily increase local blood circulation.
    Device Description
    The DPL ™ Therapy System is a compact infrared lamp for therapeutic heating. It delivers infrared light to the skin resulting in a safe elevation of the skin temperature for therapeutic effects. The device is comparable in design, technology, and output to the Dermillume HR 1000 infrared lamp product. The lamps are contained in two panels on a desk stand. The panels are detachable for use individually or as a pair on the body. The product has an automatic 17-minute timed cycle which may be repeated by activating the ON cycle. Device takes 8 minutes to reach target temperature on skin. Total time for treatment is 17 minutes.
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