Diode Laser Hair Removal Machine (models: T60A, T60B, T60C, T60D, T60E)

The KALA Therapy Wand (Model KALA-03) is an over-the-counter aesthetic device intended for treatment of facial wrinkles using red light (630nm) and mild to moderate inflammatory acne using blue light (415nm). The handheld, battery-powered wand operates for 3 minutes per treatment area with automatic 12-minute shutoff and includes vibrating massage functionality for relaxation.

The device uses LED technology with red light at 630nm (20mW/cm²) and blue light at 415nm (15mW/cm²). It is powered by a 3.7V, 500mAh lithium-ion battery and includes software-controlled microprocessor operation. The housing is aluminum, and it features a 135-degree rotatable wand head with dual switches for red light and blue light modes.

IEC 60601-1 (medical electrical equipment general safety), 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 testing for cytotoxicity, sensitization, and irritation).

The device is substantially equivalent because it is identical in design principle, intended use, indications, materials, and applicable standards to three legally marketed predicates (K241718, K161434, K242700). Although housing materials and irradiance differ slightly from predicates, these differences fall within the range of previously cleared devices and do not raise new safety or effectiveness questions. The component materials are identical to prior cleared device K232863, and non-clinical testing confirms compliance with all relevant safety and biocompatibility standards.