Solawave 2-in-1 Skincare Mini (Model: 61043)

The Solawave 2-in-1 Skincare Mini (Model 61043) is a handheld, battery-powered device that emits red light (630nm) and near-infrared light (830nm) to reduce wrinkles on the face and decolletage. It is an over-the-counter device powered by a rechargeable lithium-ion battery and also includes a warming function for non-medical purposes.

The device uses LED technology to deliver red and infrared light with a dose of 7.2–9.9 J/cm², treatment time of 3 minutes per area, and irradiances of 40–55 mW/cm² for red and infrared combined. It is handheld and powered by a DC 3.7V lithium battery (450mAh, 1.665Wh). The LED wavelengths are red 630nm ±10nm and infrared 830nm ±10nm, similar to the predicate device.

IEC 60601-1, IEC 60601-1-11, IEC 60601-2-57, IEC 60601-1-2, IEC 62471, IEC 62133-2:2017, ISO 10993-1, ISO 10993-5, ISO 10993-10, and ISO 10993-23 for electrical safety, electromagnetic compatibility, photobiological safety, battery safety, and biocompatibility.

The subject device is substantially equivalent to the predicate (ENEO TOTALE, K213841) because both are handheld, over-the-counter LED devices using identical red (630nm) and infrared (830nm) wavelengths for wrinkle treatment on the face. Although the subject device has slightly different irradiance, dose, and treatment time parameters, these differences are minimal and fall within the safe and effective range demonstrated by reference devices 1 and 2. All devices share the same regulatory class (Class II), product code (OHS), and have passed the same electrical safety and biocompatibility standards, confirming equivalent safety and performance.