Facial & Body Beauty Device (INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004, F2C15, F3222 Pro, F5516, F3606, F2210 Pro, F5808, INIA-ED001, INIA-ED002, INIA-BLD001, E1507)

The Facial & Body Beauty Device is a handheld, portable, over-the-counter aesthetic device powered by an internal rechargeable lithium battery. It delivers microcurrent electrical stimulation to facial and body skin for cosmetic purposes, with automatic shutoff after the treatment period.

The device uses regulated voltage output with bi-phase square-wave pulse waveforms delivered through a single output channel. It operates at frequencies of 3.6 kHz and 1.6 kHz in two modes, with maximum output voltages ranging from 15–23V and currents from 2–32mA depending on load impedance. It includes on/off indicators, low battery warnings, user override controls, and automatic shutoff features.

IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), IEC 60601-1-11 (home healthcare), IEC 60601-2-10 (nerve and muscle stimulators), IEC 62133-2 (lithium battery safety), ISO 10993-5 (cytotoxicity), ISO 10993-10 (skin sensitization), and ISO 10993-23 (skin irritation).

The device has the same intended use, device class (II), and product code (NFO) as two predicate devices. Its electrical parameters, waveform characteristics, and functional features are substantially similar to the predicates, with minor differences in battery capacity, dimensions, and pulse width that fall within the range of predicate device specifications and do not raise safety or efficacy concerns. Non-clinical testing confirms compliance with applicable safety standards.