K-number	K252218
Device name	MF SC GEN2 Facial Toning System
Applicant	Micro Current Technology, Inc.
Product code	NFO
Device class	Class II
Decision date	Jul 18, 2025
Decision	Substantially Equivalent
Regulation	882.5890

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

The MF SC GEN2 Facial Toning System is a transcutaneous electrical nerve stimulator (TENS) device intended to stimulate the face for over-the-counter cosmetic use. It uses electrical stimulation delivered through electrodes to tone facial muscles and skin.

Technological characteristics

Not stated in this summary.

Test standards cited

Not stated in this summary.

Substantial equivalence argument

Not stated in this summary.

Extracted by AI from the official FDA summary PDF →

Source

View the full FDA submission: accessdata.fda.gov

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MF SC GEN2 Facial Toning System

Everything you need for a 510(k) submission. Nothing you don't.