LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001)

The LUSTRE GoGlow Advanced LED Patches (Models PR8001, PR9001) is an over-the-counter light-emitting diode device for treating mild to moderate inflammatory acne. It emits blue (415nm) and red (630nm) light energy through two patch designs that attach to the skin via magnetic controllers and adhesive dots, delivering a 3-minute automated treatment session.

Each patch contains 24 LEDs (12 blue, 12 red) with irradiance of 28–35 mW/cm² and a dose of 5.04–6.3 J/cm² per 3-minute session. The device uses a rechargeable lithium-ion battery (3.7V, 200mAh) controller versus the predicate's alkaline batteries. Wavelengths are 630±10nm (red) and 415±10nm (blue), identical to the predicate device.

IEC 60601-1 (electrical safety), IEC 60601-2-83 (home light therapy equipment), IEC 60601-1-2 (electromagnetic compatibility), IEC 62471 (photobiological safety), IEC 62133-2 (lithium battery safety), ISO 10993 series (biocompatibility), IEC 62366-1 and IEC 60601-1-6 (usability).

The subject device is substantially equivalent to predicate K230720 because it shares identical intended use (OTC acne treatment), wavelengths, LED count, treatment time, product code (OLP), regulatory class (II), and biocompatible materials. Minor differences in power supply and irradiance levels are claimed to raise no safety or effectiveness concerns as all comply with applicable safety standards.