KALA MINI 2.0 (KALA-04)

The KALA MINI 2.0 is a light-emitting diode (LED) phototherapy device for home use with two modes: Mode 1 uses red and near-infrared light (660nm, 850nm) to provide topical heating for temporary relief of minor muscle and joint pain, arthritis, muscle spasm, and stiffness; Mode 2 uses red and near-infrared light (630nm, 830nm) for over-the-counter treatment of full-face wrinkles.

The device is a handheld LED panel with fixed back straps, rechargeable lithium battery, and control buttons. It offers selectable treatment times (5, 10, 15, 20 minutes) and dual brightness modes. Mode 1 delivers 100±10 mW/cm² total intensity (660nm: 50±10, 850nm: 50±10) or 7±10 mW/cm² in bedtime mode; Mode 2 delivers 90±10 mW/cm² (630nm: 45±10, 830nm: 45±10) or 7±10 mW/cm² in bedtime mode. The back enclosure contacts patient skin and is constructed of silicone.

IEC 60601-1:2005/AMD1:2012/AMD2:2020 (general safety), IEC 60601-1-2:2014+A1:2020 (electromagnetic disturbances), IEC 60601-1-11:2015/AMD1:2020 (home healthcare), IEC 60601-2-57:2011 (non-laser light sources), IEC 62471:2006 (photobiological safety), ISO 10993-5/-10/-23 (biocompatibility), IEC 62366-1 and IEC 60601-1-6 (usability).

The device employs identical light-based technology (LEDs at comparable wavelengths and intensities) to three legally marketed predicates: K242151 (wrinkle reduction), K232977 (wrinkle reduction and therapeutic heating), and K101716 (therapeutic infrared heating). Mode 1's wavelengths (660nm, 850nm) and intensity (100 mW/cm²) match or are within the range of predicate devices; Mode 2's wavelengths (630nm, 830nm) fall within predicate specifications. The device passed all applicable safety and performance standards with no new safety questions raised. Biocompatibility components are identical to previously cleared device K202390. The intended uses (wrinkle treatment and pain/stiffness relief) are substantially equivalent to predicate indications.