Regulatory tracker

FDA AI-Enabled Device Tracker:
Dermatology & Aesthetics

Every FDA marketing authorization in the dermatology and aesthetics cohort, verified against FDA's own primary documents — with the verbatim indications for use, the change-control status, and the skin-tone evidence graded for each one.

Maintained by Jane Yoo, MD, MPP Verified as of —

There is no FDA Dermatology panel. There are, now, four skin regulations.

FDA's device classification system has twenty review panels and none of them is dermatology. Skin devices are reviewed under General & Plastic Surgery, dermatopathology under Pathology, some imaging under Radiology. That is why FDA's own AI-enabled device list cannot be filtered for dermatology, and why this cohort has to be assembled by hand, one product code and regulation at a time.

But FDA is quietly building skin-specific regulatory structure anyway. Four regulations now carry this cohort — and the first two are distinguished only by whether the intended user is a dermatologist: