BTL-785BNF-E

The BTL-785BNF-E is an electrostimulation device that delivers electrical stimulation to facial, neck, and body skin for aesthetic purposes. It features a main control unit with a touch screen interface and a handheld applicator that applies biphasic rectangular pulses to stimulate skin tissue.

The device is identical to its predicate in core specifications: same waveform shape (biphasic rectangular pulse modulated by trapezoidal), same frequency (250 Hz), same power source (100-240V AC), same housing materials (PCBs in plastic/foam), same handpiece weight (2500 g) and dimensions. The only difference is introduction of a new disposable applicator (BTL-785-7-11) with 1.8 cm² conductive surface area designed to better fit the upper cheek and periocular region.

IEC 60601-1 (general electrical safety), IEC 60601-1-2 (electromagnetic compatibility), IEC 60601-2-10 (nerve and muscle stimulator requirements), IEC 60601-1-6 (usability), IEC 62304 (software lifecycle), ISO 14971 (risk management), ISO 10993-1, ISO 10993-5, and ISO 10993-10 (biocompatibility testing).

The new applicator (BTL-785-7-11) maintains the same materials (conductive ink and hydrogel), impedance range (10-5000 Ohm), duration of use (20 minutes), and electrical specifications as previously cleared applicators. Since it differs only in shape—optimized for a specific anatomical treatment area—while preserving all safety-critical electrical parameters, manufacturing processes, and technology, it presents no significant influence on safety or effectiveness and remains substantially equivalent.