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510(k) Data Aggregation

    K Number
    K162371
    Device Name
    Pulsaderm ACE-All Blue
    Manufacturer
    Nutra Luxe MD, LLC
    Date Cleared
    2016-12-15

    (113 days)

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

    Nutra Luxe MD, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Pulsaderm ACE-All Blue is indicated to treat mild to moderate acne on the face.
    Device Description
    The Pulsaderm ACE-All Blue is a device that uses Blue Light Emitting Diodes to provide LED Light therapy to the skin. Blue light is emitted for the treatment of mild to moderate acne.
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    K Number
    K161941
    Device Name
    Pulsaderm Acne Device
    Manufacturer
    NUTRA LUXE MD, LLC
    Date Cleared
    2016-10-19

    (96 days)

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

    NUTRA LUXE MD, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Pulsaderm Acne Device is intended to emit energy in the red and blue region of the spectrum, specifically indicated to treat mild to moderate acne on the face.
    Device Description
    The Pulsaderm Acne Device is a device that uses Blue and Red Light Emitting (LED) Diodes to provide LED Light therapy to the skin. A combination of red light and blue light is emitted for the treatment of mild to moderate acne.
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    K Number
    K150826
    Device Name
    Nutra Face Lift Model PE8050
    Manufacturer
    NUTRA LUXE MD, LLC
    Date Cleared
    2016-02-10

    (317 days)

    Product Code
    NFO
    Regulation Number
    882.5890
    Why did this record match?
    Applicant Name (Manufacturer) :

    NUTRA LUXE MD, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Nutra Face LIFT Model PE8050 device is intended for facial stimulation and indicated for over-the-counter cosmetic use.
    Device Description
    The Nutra Face Lift is a hand-held device intended to apply low level electrical impulses to strategic locations on the face. The Nutra Face Lift probes are designed for optimal contact with the face. The device continually alternates between the positive and negative probes and allows the user to adjust the settings from 0 to 400 microamps for personalized comfort level by pressing the up/down button. The Nutra Face Lift requires the use of a conductive derma gel. The Nutra Face Lift unit contains a power supply and internal Ni-MH rechargeable battery. The enclosure is made of medical grade biocompatibility plastics and the output contacts (Probes) consist of chrome-plated spheres. The on/off button on the unit directly allows the user to immediately remove all power from the unit.
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    K Number
    K150370
    Device Name
    Nutra Light Advanced
    Manufacturer
    NUTRA LUXE MD, LLC
    Date Cleared
    2015-07-22

    (159 days)

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

    NUTRA LUXE MD, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Nutra Light Advanced is intended/indicated for over the counter use for the treatment of mild to moderate acne and for the treatment of periorbital wrinkles and rythides.
    Device Description
    Nutra Light Advanced is a visible light and/or heat source with high spectral purity. The device is made of Lustran ABS 348 with clear cover lenses covering the LED light sources. The device has two exchangeable heads; with one head emitting narrow band blue light at 410mm for the treatment of mild to moderate acne vulgaris, the other head emits red light at 650mm for the treatment of periorbital wrinkles and rhytides. The device consists of a basic-hand-held, battery operated control unit and two optional (Blue and Red LED) interchangeable heads, which allows the operator to select either the blue or red operation. The STOP button directly on the unit allows the user to immediately remove all power to the unit. The device does not allow the operator to select the red and blue light simultaneously.
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    K Number
    K141588
    Device Name
    NUTRA STIM HAIR LASER COMB
    Manufacturer
    NUTRA LUXE MD, LLC
    Date Cleared
    2015-01-08

    (209 days)

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

    NUTRA LUXE MD, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Nutra Stim Hair Laser Comb is indicated to treat androgenetic alopecia and promote hair growth in females who have Ludwig (Savin) Scale I-4, LL-1, LL-2, or frontal and Fitzpatrick Skin Types L to IV.
    Device Description
    The Nutra Stim Hair Laser Comb is a hand-held low level laser device that emits laser light with the intention to promote hair growth. The device provides distributed laser light to the scalp while the comb teeth simultaneously part the user's hair to ensure the laser light reaches the user's scalp. The Nutra Stim Hair Laser Comb unit contains the power supply, internal NI-MH rechargeable battery and the control unit. The enclosure and laser lens are made of medical grade biocompatibility plastics via injection molding. The STOP button directly on the unit allows the user to immediately remove all power to the unit. The Nutra Stim Hair Laser Comb does not use any software.
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    K Number
    K141596
    Device Name
    NUTRA STIM HAIR LASER COMB
    Manufacturer
    NUTRA LUXE MD, LLC
    Date Cleared
    2015-01-08

    (209 days)

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

    NUTRA LUXE MD, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Nutra Stim Hair Laser Comb is indicated to treat androgenetic alopecia, promote hair growth and prevent further hair loss in males who have Norwood Hamilton Classifications of IIa to V patterns of hair loss and Fitzpatrick Skin Types I to IV.
    Device Description
    The Nutra Stim Hair Laser Comb is a hand-held low level laser device that emits laser light with the intention to promote hair growth. The device provides distributed laser light to the scalp while the comb teeth simultaneously part the user's hair to ensure the laser light reaches the user's scalp. The Nutra Stim Hair Laser Comb unit contains the power supply, internal NI-MH rechargeable battery and the control unit. The enclosure and laser lens are made of medical grade biocompatibility plastics via injection molding. The STOP button directly on the unit allows the user to immediately remove all power to the unit. The Nutra Stim Hair Laser Comb does not use any software.
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    K Number
    K141308
    Device Name
    NUTRA LIGHT RED
    Manufacturer
    NUTRA LUXE MD, LLC
    Date Cleared
    2014-08-20

    (93 days)

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

    NUTRA LUXE MD, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Nutra Light Red is a non-invasive LED light device is intended/indicated for over- the -counter use for the treatment of periorbital wrinkles, and rhytides
    Device Description
    The NutraLuxe Red, Model NL-2212 is a device that utilizes Light Emitting Diodes to provide LED light to the body. The NutraLuxe Red is a visible light source of high spectral purity. They provide uniform or "hot-spot" free illumination. The output is pre-tuned to one wavelength with a narrow spectral bandwidth. The output wavelength of Red is 650 +/- 5 at 80 mW. The NutraLuxe Red unit contains the power supply, internal NI-MH rechargeable battery and the control unit. The enclosure and LED lens are made of medical grade biocompatibility plastics via injection molding. It has the capabilities to deliver the light to the skin as the unit is moved over the STOP button directly on the unit allows the user to immediately remove all power to the unit. The Nutra Light Red does not use any software.
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    K Number
    K132838
    Device Name
    NUTRA LIGHT BLUE
    Manufacturer
    NUTRA LUXE MD, LLC
    Date Cleared
    2014-05-23

    (255 days)

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

    NUTRA LUXE MD, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Nutra Light Blue is a non-invasive LED light device is intended/indicated for over- the-counter use. The device delivers low intensity light emitting diodes (LED's) in the blue region at a wavelength of 410 +/- 5 nanometers, for the treatment of mild to moderate inflammatory acne.
    Device Description
    The Nutra Light Blue Model: NL-2213, is deviccs that utilize Light Emitting Diodes to provide LED light to the body. The Nutra Light Blue is a visible light source of high spectral purity. They provide uniform or "hot-spot" free illumination. The output is pre-tuned to one wavelength with a narrow spectral bandwidth. The output wavelength of Blue is 410 +/- 5 at 75 mW. The Nutra Light Blue unit contains the power supplies, internal NI-MH rechargeable battery and the control unit. The enclosure and LED lens are made of medical grade biocompatility plastics via injection molding. It has the capabilities to deliver the light to the skin as the unit is moved over the skin surface. The STOP button directly on the unit allows the user to immediately remove all power to the unit. The Nutra Light Blue does not use any software.
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