Certified skin and dermatology apps
7 skin apps and devices, each checked against the FDA register, EUDAMED and the German DiGA directory. Last checked 18 October 2026.
Skin cancer apps are among the most searched health apps, and among the most misunderstood. In the US, the authorised tool in this area is for physicians, not consumers. In Europe, several apps for checking skin spots hold a CE certificate of class IIa.
Below you find every skin tool we track, grouped by what we could verify in the official registers.
In the US: FDA verified
Authorised by the FDA (510(k), De Novo or PMA), newest decisions first.
In the EU: CE class IIa or higher
Found in EUDAMED as class IIa or higher. We show whether a notified body certificate is visible there.
CE class I (self-declared)
Self-declared by the maker, without review by a notified body. We list these apart.
Watchlist
These products are presented as certified, by their maker or in earlier directories, but we found no matching record in the official register, or they are no longer supported by their maker. Some are registered and listed with the FDA as exempt devices, which is legal but is not a clearance.
The trap to avoid
No app replaces a dermatologist for a suspicious spot. A CE class IIa app has been reviewed for what it claims, which is usually risk assessment and referral, not diagnosis. In the US, we found no consumer skin cancer app with FDA authorisation.
Questions
Is there an FDA-authorised skin cancer app?
Not for consumers in our directory. DermaSensor, authorised through the De Novo route in 2024, is a handheld device for primary care physicians.
Is SkinVision certified?
SkinVision carries CE class IIa in the EU. We found no FDA record for it.
Can I get a dermatologist's opinion online?
In our directory, dermanostic and OnlineDoctor Hautcheck carry CE class IIa in the EU.
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