Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)

The Micro-current Facial Beauty Device is a handheld, portable, over-the-counter aesthetic device intended for treatment of facial wrinkles and mild to moderate inflammatory acne. It delivers micro-current electrical stimulation through two electrode massage heads, provides LED light therapy (amber, red, and blue wavelengths), and includes hot compress and vibration functions for facial and neck skin treatment.

The device uses biphasic pulsed square waveforms at 57Hz with maximum output of 225mV–3.60V (load-dependent) and 450μA maximum current, delivering 4ms pulse width. It features a rechargeable 3.7V lithium battery (600mAh), software control, handheld design, and weighs 118–130g depending on model. Key differences from predicates include lower current density (0.06–0.10mA/cm² versus 0.33–0.49mA/cm² in predicates) and different dimensions, but electrical parameters remain within similar ranges.

Biocompatibility testing per ISO 10993-5 (cytotoxicity), ISO 10993-10 (skin sensitization), and ISO 10993-23 (irritation). Electrical safety compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-10 (nerve and muscle stimulators), and IEC 62133-2 (lithium battery safety). Software verification and validation per Basic Documentation Level.

The subject device shares the same intended use (facial aesthetic stimulation for wrinkles and acne), identical regulatory classification (Class II, product code NFO), identical waveform type (biphasic square), and similar electrical output ranges as three legally-marketed predicates (K171821, K213039, K233010). Although it has lower current density and different dimensions, these differences do not raise safety or efficacy concerns because biocompatibility and electrical safety testing confirm the device is safe, and the lower stimulation parameters represent a more conservative design approach compared to predicates.