DeepSkin receives US clearance as an aesthetic electrical stimulator
The FDA database lists the DEP100 as substantially equivalent in a May 2026 decision.
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The answer first
The FDA’s 510(k) database records DeepSkin DEP100 as a transcutaneous electrical stimulator for aesthetic purposes, with a substantially-equivalent decision dated 8 May 2026.
Why it matters
“FDA cleared” describes a specific device, intended use and regulatory route. It should not be stretched into proof for every claim made around a treatment.
What the database confirms
The FDA record identifies the device classification as a transcutaneous electrical stimulator for aesthetic purposes. The 510(k) decision is listed as substantially equivalent, with the application reviewed under the Neurology panel.
That record confirms a regulatory pathway and device identity. It does not by itself tell a consumer how large an aesthetic effect to expect, how results compare with alternatives or whether a particular clinic is using the cleared device as labelled.
How to read aesthetic-device claims
Check the exact device name, cleared indication, treatment protocol, operator qualifications, contraindications and the evidence supporting the promised outcome. “FDA registered,” “FDA cleared” and “FDA approved” are not interchangeable.
Anecdotal links to the regulator’s record so the status can be checked independently rather than relying on a clinic’s summary.
Regulatory status from the FDA 510(k) database. This is not an independent treatment review.
Primary sources
Check the underlying record.
- 01510(k) Premarket Notification K252621regulator
US Food and Drug Administration · 2026-05-08
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