Jmoon Conductive Gel

Jmoon Conductive Gel is a clear, viscous, chloride-free gel intended for use with microcurrent devices to improve skin conductivity by reducing impedance at the electrode-skin interface. It is applied under electrodes on intact skin and is designed for over-the-counter use by adults 18 years or older in a home environment.

The subject device uses sodium salt as its conductive material with a pH range of 5.0-7.0, compared to the predicate device NuFACE Gel Primer which uses magnesium sulfate salt with pH 6.0-7.0. Both are non-sterile, non-OSHA PEL formulations intended for the same target population and body contact (intact skin). The subject device additionally complies with ISO 10993-23 biocompatibility testing, whereas the predicate device does not explicitly list this standard.

ISO 10993-1 (Biological Evaluation—Risk Management Process), ISO 10993-5 (In Vitro Cytotoxicity), ISO 10993-10 (Skin Sensitization), ISO 10993-23 (Irritation). Testing also included accelerated stability testing (3-year shelf life validation) and performance characterization (appearance, color, odor, microbiological growth, pH, conductivity, and viscosity).

The subject device has the same intended use, target population, environment of use, and body contact site as the predicate device. Although the conductive salt differs slightly (sodium vs. magnesium sulfate) and the pH range is marginally broader (5.0-7.0 vs. 6.0-7.0), both formulations use salts and maintain pH values close to human skin surface pH, so these differences do not raise safety or effectiveness concerns. Performance testing demonstrates the subject device meets its intended specifications, and biocompatibility testing confirms safety comparable to the predicate.