Red Light Therapy for Face – PRUNGO LED Mask with 3 Light Modes, Portable Rechargeable Device, 850nm Infrared, Lightweight & Comfortable with Remote Control and Timer, Equipped with 280 LED Lights

4.5 stars FDA cleared!
This is my first red-light face mask though I’ve used many red-light devices.  For this one there seems to be a disconnect btwn the product page and the actual mask, because it comes with 8 light settings, not 3.  Regardless, I expect that most people will use the main 3 lights (red, blue, NIR), and that the other light settings are probably diff combos of these 3.The easiest way to review this is based on the super important words on lower right of package – “FDA cleared” (!).  Not a single one of my other devices has had this distinction. To be clear, it’s not “FDA “approved” (which requires clinical trial data); rather it means that the FDA has declared it ok to use based on similarity to other devices the FDA has already reviewed. Bottom line: “FDA cleared” is used to imply safety and effectiveness similar to a previously marketed FDA-reviewed device. It’s essentially a seal of approval, something not all devices get before rushing to market. (Fwiw, the FDA clearance likely also raises the price…) The mask is a floppy one so I don’t feel claustrophobic as I would with a solid mask (in case anyone else has claustrophobia). The head band closure is strange but provides size flexibility so you can make it tight to your face, and I find that the eye goggles fit me fine. Overall it’s comfortable enough I even work while wearing, so I leave it next to my laptop and it easily fits into my routine. My only complaint is I wish the mouth hole were not as big so it would cover more of the area around my lips. That aside, I’ve had great luck with red light devices for body inflammation or restlessness so I do believe this will do something.Small points of confusion: The timer allows either 5 or 10 min exposures, but unfortunately the instructions are skeletal so I’m not sure if that means you can do 10 min per each light setting, or 10 min total. One weird thing is that the Near-Infrared (NIR) setting still shows as visible red light, yet humans can’t see NIR light. So either it’s not NIR or they’ve decided to put NIR together with visible red light to do both at the same time (which is how most red light devices do it). I don’t know the answer but hope the latter is correct. Again, the instructions aren’t great. Finally, 4W seems like a low dosage and when I do the calculations it comes out to a small power per cm2. Yet, PrunGO is very well-known in this space and went to the effort to market an FDA cleared device, so I want to give them the benefit of the doubt over my calculations.  All together though, those are my reasons for subtracting 1/2 star. (PS – you can check it out in the FDA device database, but you have to look up the manufacturer, Shenzhen Rainbow Technology Co, not PrunGO.) 

Shenzhen Rainbow RB-008G Mask
First things first, I am most concerned about the quality of this mask, as it would be pointless to waste your money on something that is a fake, or not government approved. After some research, this PrunGo mask does appear to be a custom branded Shenzhen Rainbow RB-008G Red Light Therapy Mask. The mask comes with a remote that holds the charge and can be charged with a USB-C cable when not in use. I found the mask effective and easy to use, and did not notice any skin irritation after using it. The mask also has 8 different modes, making it very versatile for a number of treatment solutions. This mask is also an excellent value for the money, as other brands have sold this same mask for a much higher price.The following are highlights from the FDA 510(k) summary for this product:The LED Light Therapy Mask has the same wavelengths (red: 620nm, blue: 460nm, infrared: 850nm) as K223544 and they all comply with IEC 60601-2-83 and IEC 62471 requirements, so it will not raise any safety or effectiveness issue.Though the irradiance of subject device is a little different from the predicate device and reference devices, the irradiance of subject device is within the range of the minimum and maximum value of the predicate device and reference predicate devices, and the subject device complies with IEC 60601-2-83 and IEC 62471 requirements, so this difference will not raise any safety or effectiveness issue. The evaluation process is as follows:a. Red+IR light: the irradiance of subject device (45.5mW/cm2) is between the range of K241857 (30mW/cm2) and K241102 (63mW/cm2).b. Red light: the irradiance of subject device (53.2mW/cm2) is within the range of the red light irradiance (31~75mW/cm2) of K230351.c. Infrared light: the irradiance of subject device (4mW/cm2) is the same as the K223544.d. Blue light: the irradiance of subject device (58.7mW/cm2) is within the range of the blue light irradiance (15~63mW/cm2) of K230351.e. Red and blue light: the irradiance of subject device (33.6mW/cm2) is similar with the K160691(34mW/cm2)