Two layers that matter
The stratum corneum is the outer layer of the epidermis: flat, keratinized, non-living cells that the skin sheds naturally. Everything below it, meaning the rest of the epidermis, the dermis, follicles and glands, FDA calls the living layers of skin.FDA guidance 2020
Why the line matters to a buyer
In its microneedling guidance FDA says that claims about disrupting or removing the stratum corneum, exfoliating, or improving the appearance of skin do not, on their own, show an intent to affect the body’s structure or function. Claims that a product reaches living layers, stimulates collagen or treats wrinkles do.FDA guidance 2020
Dermabrasion devices are Class I and 510(k)-exempt; microneedling devices for aesthetic use are Class II and need a 510(k).FDA guidance 2020 A needle-free prep device whose maker describes it as working on the stratum corneum sits with the first group, and should be described that way, with the maker’s description attributed to the maker.
How to talk about it with patients
Describe what the step does (exfoliation of the outer layer before a topical product) and keep any statement about results to appearance. We can provide claims-safe patient-facing copy for the devices we place: see what practices receive.
General information for licensed practices, not legal or medical advice. Sources are linked in the text.