Search Results
Found 2 results
510(k) Data Aggregation
K Number
K140471Device Name
PRO X OTC 5
Manufacturer
LA LUMIERE, LLC
Date Cleared
2015-01-15
(324 days)
Product Code
OHS
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
LA LUMIERE, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Pro X OTC 5 is an Over-The-Counter device intended for use in the treatment of facial wrinkles. It is for people with wrinkles on their face and who have Fitzpatrick skin types I, II and/or III.
Device Description
The Pro X OTC 5 is an Over-the-Counter device intended for use in the treatment of facial wrinkles. Facial wrinkles are lines on the skin that appear as you age. Facial wrinkles can appear anywhere on the face, such as on the forehead, around the eyes, and by the mouth. The Pro X OTC 5 is for people with wrinkles on their face and who have Fitzpatrick skin types I, II, and/or III.
The Pro X OTC 5 uses known LED light therapy technology. A combination of red light (620-630mm) and infrared light (855nm) is emitted. To use the Pro X OTC 5 device, users place the lightweight mask over the face and then press the "On" button on the controller to start treatment. The device will automatically turn off after each treatment cycle.
The Pro X OTC 5 device is designed to be used for 30 treatment sessions. The full treatment regimen for facial wrinkles includes 60 individual treatments, therefore purchase of two (2) devices is needed to receive the full treatment regimen.
Ask a Question
K Number
K123999Device Name
ILLUMASK ACNE LIGHT THERAPY MASK
Manufacturer
LA LUMIERE, LLC
Date Cleared
2013-08-28
(245 days)
Product Code
OLP
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
LA LUMIERE, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The illuMask Acne Light Therapy Mask 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 IlluMask Acne Light Therapy device uses known LED light therapy technology for the treatment of mild to moderate acne. A combination of red light (630mm) and blue light (445nm) is emitted. Users place the lightweight mask over the face press the On button on the controller button to start treatment. The device will automatically turn off after each treatment, and there is a total of 30 treatments.
Ask a Question
Page 1 of 1