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., Ya-Man, Ltd. and A-1 Engineering.
FDA 510(k) Cleared Stimulator, Transcutaneous Electrical, Aesthetic Purposes Devices (Product Code NFO)
About Product Code NFO - Regulatory Context
510(k) Submission Activity
75 total 510(k) submissions under product code NFO since 2001, with 75 receiving FDA clearance (average review time: 213 days).
Submission volume has increased in recent years - 20 submissions in the last 24 months compared to 11 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under NFO have taken an average of 134 days to reach a decision - down from 241 days historically, suggesting improved FDA processing for this classification.
NFO devices are reviewed by the Neurology panel. Browse all Neurology devices →