PureLift GLOW

The PureLift GLOW is a handheld, over-the-counter cosmetic device that delivers microcurrent electrical impulses and LED light (red 634nm and blue 465nm wavelengths) to the face and neck. It is intended for facial and neck stimulation, treatment of wrinkles, treatment of mild to moderate inflammatory acne, and cosmetic use.

The device uses microcurrent energy with rectangular pulses at 1.37–1.73 kHz, outputting up to 9mA at 500Ω impedance. It features two output modes, a single channel, regulated current output, and a 10-minute treatment timer. The device includes an LED treatment area of approximately 36.3cm² with both red (634nm) and blue (465nm) wavelengths, powered by a single 3.7V rechargeable battery with automatic shut-off and an indicator display.

The device complies with ANSI/AAMI ES60601-1 and IEC 60601-1-2 electrical safety standards. Biocompatibility testing followed ISO 10993-5 and ISO 10993-10. Bench performance testing covered power input, voltage/current limitations, leakage currents, dielectric strength, accessible parts, acoustic energy, drop tests, temperature, and vibration.

The PureLift GLOW is substantially equivalent to the PureLift Pro Plus (K221443) predicate because both devices use identical microcurrent waveform parameters (monophasic rectangular pulses, 1.37–1.73 kHz, 4µs phase duration, 30 pulses per burst, same output current and voltage specifications), share the same materials (thermoplastic resin with chrome-plated spheres), employ the same regulated current architecture, and meet the same electrical safety standards. The addition of LED wavelengths (634nm and 465nm) for wrinkle and acne treatment expands the indications and is supported by bench testing; the comparison to reVive Light Therapy (K223482) demonstrates that LED irradiance sources are accepted for similar cosmetic indications in this device class.