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510(k) Data Aggregation

    K Number
    K233862
    Device Name
    NUNA LUX (NUNL528)
    Manufacturer
    Premier North America Inc.
    Date Cleared
    2024-03-01

    (86 days)

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

    Premier North America Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NUNA LUX is an Over-the-Counter (OTC) light based device intended for the use in treating full-face wrinkles.
    Device Description
    The NUNA LUX is an Over-the-Counter (OTC) light based device intended for the use in treating full-face wrinkles. NUNA LUX is a battery-operated device that uses low power light spectrum at red and infrared, at wavelength of 808 ±5nm, 620 ±5nm emitting optical power in a uniform distribution. The NUNA LUX incorporates a near-infrared LED light source within the optimum Therapeutic Optical Window at 808 nm, optimized for Low Level Light Therapy, and a red LED light source at 620 nm. An optical lens that diffuses the light to produce narrowband, divergent distribution across an 8 cm2 treatment area. The energy output of the 808 nm and 620 nm wavelengths is 62.5 mW/cm2 which produces a beneficial treatment for full-face wrinkles.
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    K Number
    K232656
    Device Name
    BLU TOTALE (Model: ENEOB852)
    Manufacturer
    Premier North America Inc.
    Date Cleared
    2023-11-14

    (75 days)

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

    Premier North America Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BLU TOTALE is an over the counter phototherapy device for use in dermatology for the treatment of mild to moderate acne.
    Device Description
    BLU TOTALE is a battery-operated device that uses low power light spectrum at blue LED, at wavelength of 415 ±15nm emitting optical power in a uniform distribution with no hot spots. It is a hand held light emitting diode (LED) device for the treatment of acne designed for home-use.
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    K Number
    K220735
    Device Name
    Avologi Gel Primer (Model: Av25)
    Manufacturer
    Premier North America Inc.
    Date Cleared
    2023-09-15

    (550 days)

    Product Code
    GYB
    Regulation Number
    882.1275
    Why did this record match?
    Applicant Name (Manufacturer) :

    Premier North America Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Avologi Gel Primer is intended to be used with Luminice device to improve skin conductivity.
    Device Description
    The Avologi Gel Primer is a clear, viscous and chloride-free formulation. The gel is to be applied to the area under an electrode to reduce the impedance of the contact interface between the electrode surface and the skin.
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    K Number
    K214100
    Device Name
    Luminice
    Manufacturer
    Premier North America Inc.
    Date Cleared
    2022-02-24

    (57 days)

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

    Premier North America Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Luminice is intended for body skin stimulation and is indicated for over-the-counter cosmetic use.
    Device Description
    Luminice is intended for body skin stimulation and is indicated for over-the-counter cosmetic use. Four (4) stainless steel electrodes, fixed on the Luminice device main body, deliver low level electrical impulses (microcurrent) to targeted locations on the body. The Luminice should be used with 510(k) clearance electroconductive media gel, and it's compatible with NuFACE Gel Primer cleared under K161654.
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    K Number
    K213841
    Device Name
    ENEO TOTALE (Model: ENEOT947)
    Manufacturer
    Premier North America Inc.
    Date Cleared
    2022-01-06

    (28 days)

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

    Premier North America Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ENEO TOTALE is an over the counter device indicated to emit energy in the red and IR region of the spectrum for use in dermatology for the treatment of periorbital wrinkles.
    Device Description
    ENEO TOTALE is a battery-operated device that uses low power light spectrum at red and infrared LED, at wavelength of 633 ±5nm, 830 ±5nm emitting optical power in a uniform distribution with no hot spots. It is a hand held light emitting diode(LED) device for the treatment of periorbital wrinkles designed for home-use.
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    K Number
    K181659
    Device Name
    Avologi ENEO
    Manufacturer
    Premier North America Inc.
    Date Cleared
    2018-07-26

    (31 days)

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

    Premier North America Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Avologi ENEO is an over the counter device indicated to emit energy in the red and IR region of the spectrum for use in dermatology for the treatment of periorbital wrinkles.
    Device Description
    Avologi ENEO is a battery operated device that uses low power light spectrum at red and infrared LED, at wavelength of 633±5nm, 830±5nm emitting optical power in a uniform distribution with no hot spots. It is a hand held light emitting diode(LED) device for the treatment of periorbital wrinkles designed for home-use.
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