LED Face Mask Wrinkle Claims: Where the FDA Product Code Puts Them
Copy for at-home LED masks often carries a regulation number, something like 21 CFR 878.4810. That number establishes less than it appears to.
In the US record the field that carries the intended use is not the regulation number but the product code. This piece reads the public classification records for two codes side by side.
One regulation number, two different uses
The code for wrinkles is OHS. Its classification record names it light based over the counter wrinkle reduction, Class II, under 21 CFR 878.4810.
The code for hair removal is OHT. It is named light-based over-the-counter hair removal, also Class II, also under 21 CFR 878.4810.
Regulation number, device class and review panel are identical across the two. What differs is the name of the code and the use described beneath it.
The use fields describe what the device is said to do
OHS is defined as the use of light based treatment to reduce wrinkles on the body in general or specific anatomical locations depending on the information provided. Its technical method reads: light based energy delivered to and or through the skin to effect change in the tissue that results in the reduction of wrinkles.
OHT describes something else entirely — the use of thermal energy to kill hair follicles for hair removal. The shared regulation number does not make the described mechanisms the same.
Both records list the submission type as 510(k) and the status as over-the-counter. These are boxes built for devices operated without supervision.
Three fields, not one number
A claim that cites only a regulation number is closer to atmosphere than to information. Checking it takes the product code and the individual K number as well, and then a comparison between the use recorded there and the use being advertised.
The same logic limits what a single clearance covers. A device reviewed for wrinkles has not thereby been reviewed for acne, pigmentation or hair growth. A different code is a different record.
What has been checked here ends at those two classification records. Which code and K number any particular product holds has to be looked up product by product, and a US record does not stand in for another market’s status.
Sources checked
Scope — This article explains devices and technology. It does not provide individual diagnosis or treatment advice.