Frequently Asked Questions (FAQ)

FDA-cleared, what does that mean?

Mypurmist is a Class II device and "Cleared" for sale Over The Counter (OTC i.e. without a prescription) by the FDA. Red Light Therapy devices are never "Approved" by the FDA. Only drugs and some Class III devices are designated  "Approved". The Cleared designation means Mypurskin is developed and manufactured using medical-grade materials and in a "clean" aseptic factory using Good Manufacturing Practices (GMP) and certified for medical devices (ISO13485). It means that the FDA considers the device safe and effective provided the product is designed and manufactured in a medical-grade facility using medical-grade materials.

 

What is irradiance?

Irradiance is defined as the light intensity (or brightness) reaching the skin every second. It is measured as milliwatts per square centimeter (mW/cm²). Typical high-end LED masks have an irradiance of 8-30 mW/cm². Mypurskin have a higher irradiance of 53 mW/cm², more typical of levels of irradiance used in peer-reviewed clinical studies. It is important to understand that the Irradiance quickly drops with distance from the skin. At a distance of just 0.5 inch from the LED, the irradiance is 5 times lower. At 1 inch it is 10 times lower. Mypurskin's face-shaping design provides for a convenient way to keep LEDs close to the skin for maximum effectiveness.

 

What is Light Dose?

Light Dose is also called Fluence in scientific publications and in light science. Fluence is the cumulative amount of Irradiance reaching the skin over a session. Fluence is measured a Joules per square centimeter or J/cm². Joules is a measure of energy. Most high-level LED masks have Fluence levels well below what was used in published clinical studies. The levels used in clinical studies for facial treatment are reported to be 4 to 50 J/cm².

 

Why is number of LEDs important?

It is critical to cover the entire surface of the face with light to make the treatment effective. A simple example would be if one mask has one single LED in the middle and another have a hundred spread all over the mask. Surely a single LED would not be effective, and a hundred would be much better. Mypurskin has 264 LEDs and more than any other high-end LED mask. This amount of LEDs provides a coverage that ensures a dose of light (Fluence) across the entire face area similarly to what was used in clinical studies.

 

What is wavelength and what does it mean?

Think of wavelength as the color of the light. It is measured in nanometers (nm). At one end is <400 nm UV light which is high-energy invisible light - and which can damage DNA. Then, as we move across the colors, comes the violet, blue, cyan, green, and yellow colors we can see. As we get towards the red range of colors the dangerous energy levels have dropped. Mypurskin uses three red and one infrared wavelengths (590, 633, 660 and 830 nm). The deeper the red color, the deeper the light reaching into the skin. All of these four wavelengths have been proven in clinical studies to have many beneficial effects on skin, and yet being super gentle on the skin and eyes. Other leading LED masks typically have just one or two red/infrared wavelengths (e.g. Omnilux, CurrentBody, Aphrona, etc.).

How do masks compare?

Irradiance, fluence (light dose), and wavelengths are all critical to the effectiveness of an LED mask. Below you'll see the spectrograms of leading LED masks compared to Mypurskin. A spectrogram shows the wavelengths emitted and their relative size or peak is the irradiance (light intensity).