KALA Therapy Wand (Model: KALA-03)

The KALA Therapy Wand (Model KALA-03) is an over-the-counter handheld device intended for aesthetic use to treat facial wrinkles and mild to moderate inflammatory acne. It uses red LED light (630nm) for wrinkle treatment and blue LED light (415nm) for acne treatment, with vibration functionality. The device is battery-powered, automatically shuts down after 12 minutes, and includes protective goggles and a storage case.

The device uses red LEDs at 630nm with 20mW/cm² irradiance and blue LEDs at 415nm with 15mW/cm² irradiance. Treatment time is 3 minutes per area with 12 minutes maximum per session. It is powered by a 3.7V lithium-ion battery (500mAh, 1.85Wh) and includes microprocessor control with software. The housing is aluminum with a 135-degree rotatable wand design.

IEC 60601-1 (medical electrical equipment general requirements), IEC 60601-1-11 (home healthcare environment), IEC 60601-2-57 (non-laser light source equipment), IEC 60601-1-2 (electromagnetic compatibility), IEC 62471 (photobiological safety), IEC 62133-2 (lithium battery safety), and ISO 10993-5/10 (biocompatibility for cytotoxicity and irritation).

The device is substantially equivalent because it shares the same design principle, intended use, indications, functions, and applicable standards (21 CFR 878.4810, Class II) as three cleared predicate devices. While irradiance levels differ slightly (red: 20mW/cm², blue: 15mW/cm²), these fall within the ranges of previously cleared devices (K241718, K161434, K242700). Material differences (aluminum housing) and treatment time variations (3 minutes per area) do not raise new safety or effectiveness questions as they comply with applicable IEC standards and biocompatibility requirements identical to predicates.