DeepSkin (DEP100)

The DEP100 is a handheld, battery-powered, over-the-counter cosmetic device that delivers microcurrent electrical stimulation to facial skin for aesthetic purposes. It is non-invasive and non-ablative, used with conductive gel, and intended for home use by healthy adults on intact facial skin.

The DEP100 and predicate device (Nu Skin Facial Spa) both use direct current microcurrent technology with identical electrical specifications (~200 mV @ 500 Ω, ~800 mV @ 2 kΩ, ~4 V @ 10 kΩ maximum output voltage; ~400 µA maximum output current). Key differences include battery type (rechargeable Li-ion vs. AAA alkaline), slightly larger electrode sizes on the DEP100, and updated IEC 60601 standards compliance (2005/2014/2015 editions vs. 1998/2012/1987 editions).

IEC 60601-1:2005, IEC 60601-1-2:2014, IEC 60601-1-11:2015, IEC 60601-2-10:2012 for electrical safety and electromagnetic compatibility; ISO 10993-1 for biocompatibility; ISO 13485 for quality management; REACH and RoHS for material composition; IEC 60601-1-6:2010 for human factors validation.

The DEP100 is substantially equivalent because it shares the same intended use (facial stimulation for OTC cosmetic use), identical technological principle (microcurrent direct current stimulation), matching electrical performance specifications, and equivalent safety features and materials as the predicate device. Minor differences in battery type, electrode size, and updated standards compliance do not raise new safety or effectiveness concerns and are supported by comprehensive bench testing.