SmartAppGuidedTM MicroCurrent Face-Lift Pen 6 in 1

The SmartAppGuided MicroCurrent Face-Lift Pen | 6 in 1 is an over-the-counter cosmetic device intended for stimulation of neck and facial skin. It is powered by a rechargeable lithium-ion battery and delivers microcurrent through two fixed spherical electrodes with three adjustable intensity levels and automatic 3-minute shut-off.

The device delivers pulsed biphasic microcurrent at approximately 8.3 Hz with 60 ms pulse width, maximum output voltage of 25.2 VDC (no load), and maximum output current of 760 μA at 500Ω. It is compact (1.14" × 0.99" × 3.9"), lightweight (1.3 oz), housed in ABS with silicone, and features stainless steel or titanium-gold plated electrodes. Unlike predicate devices, it lacks a visual indicator display but provides tactile and auditory feedback instead.

IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-11, IEC 60601-2-10, IEC 60529, IEC 62366, IEC 62133, ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-12, ISO 10993-23, and ISO 14971. Compliance with 21 CFR 898 was also demonstrated.

The device shares the same intended use, regulatory classification (Class II, Product Code NFO), and operational principle (transcutaneous electrical nerve stimulation) as three predicate devices. Although minor differences exist in dimensions, housing materials, electrode materials, and output voltage/current, these do not introduce new safety risks: the subject device's output current (760 μA) falls between predicates (400–900 μA), current density remains within ±20% of predicate Device 2 and far below IEC 60601-2-10 limits (50 mA), biocompatibility testing confirmed no adverse skin reactions, and the lack of visual indicator is functionally compensated by tactile/auditory feedback. All devices comply with the same electrical safety and EMC standards, establishing that the subject device is as safe and effective as the predicates for OTC cosmetic use.