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Found 6 results
510(k) Data Aggregation
K Number
K233862Device Name
NUNA LUX (NUNL528)
Manufacturer
Premier North America Inc.
Date Cleared
2024-03-01
(86 days)
Product Code
OHS
Regulation Number
878.4810Why 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
K232656Device Name
BLU TOTALE (Model: ENEOB852)
Manufacturer
Premier North America Inc.
Date Cleared
2023-11-14
(75 days)
Product Code
OLP
Regulation Number
878.4810Why 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
K220735Device Name
Avologi Gel Primer (Model: Av25)
Manufacturer
Premier North America Inc.
Date Cleared
2023-09-15
(550 days)
Product Code
GYB
Regulation Number
882.1275Why 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
K214100Device Name
Luminice
Manufacturer
Premier North America Inc.
Date Cleared
2022-02-24
(57 days)
Product Code
NFO
Regulation Number
882.5890Why 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
K213841Device Name
ENEO TOTALE (Model: ENEOT947)
Manufacturer
Premier North America Inc.
Date Cleared
2022-01-06
(28 days)
Product Code
OHS
Regulation Number
878.4810Why 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
K181659Device Name
Avologi ENEO
Manufacturer
Premier North America Inc.
Date Cleared
2018-07-26
(31 days)
Product Code
OHS
Regulation Number
878.4810Why 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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