308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K)

The 308nm Excimer Phototherapy Device is a handheld ultraviolet light therapy system intended for treating psoriasis and vitiligo on intact skin only. It operates non-continuously and delivers 308nm wavelength UV radiation with adjustable treatment times from 0–120 seconds.

The proposed device has treatment areas ranging from 8 cm² to 30 cm² (depending on model), UV irradiation intensity of 10–70 mW/cm², and a maximum dose of 5000 mJ/cm². It features an 8-inch touch LCD display, air cooling of the light source, manual MED testing, and is classified as Class II anti-electric shock (Type BF). Power inputs vary by model (40–200 VA).

IEC 60601-1:2020, IEC 60601-1-2:2020, IEC 60601-2-83:2019, IEC 60601-1-11:2020, IEC 62471:2006, ISO 10993-5:2009, ISO 10993-10:2021, ISO 10993-23:2021. Testing included electrical safety, electromagnetic compatibility, photobiological safety, biocompatibility, software validation, and equipment performance verification.

The proposed device shares identical indications for use, wavelength, operation mode, and maximum dose with predicate K200971. Minor differences—such as expanded treatment areas across multiple models, slightly higher maximum irradiation intensity (10–70 vs. 50 mW/cm²), and Class II vs. Class I electrical classification—do not raise new safety or effectiveness concerns because all models passed the same comprehensive testing standards and the differences remain within clinically acceptable parameters for home phototherapy equipment.