FDA Product Code NFO: Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Under FDA product code NFO, transcutaneous electrical nerve stimulators for aesthetic purposes are cleared for cosmetic skin treatments.
These devices deliver low-level electrical stimuli to facial and body skin for cosmetic toning and firming applications, stimulating muscle contractions and improving skin appearance. They are distinct from therapeutic TENS devices cleared for pain management.
NFO devices are Class II medical devices, regulated under 21 CFR 882.5890 and reviewed by the FDA Neurology panel.
Leading manufacturers include BTL Industries, Inc. and Shenzhen Ulike Smart Electronics Co., Ltd..
List of Stimulator, Transcutaneous Electrical, Aesthetic Purposes devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Stimulator, Transcutaneous Electrical, Aesthetic Purposes devices (product code NFO). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Neurology FDA review panel. Browse all Neurology devices →