308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV Phototherapy System (UV-Y); 308nm UV Phototherapy System (UV-Z)

The 308nm UV Phototherapy System is a portable handheld medical device that emits narrowband UVB light at 308nm wavelength for localized treatment of skin disorders including psoriasis, vitiligo, seborrheic dermatitis, atopic dermatitis, and leukoderma. It is available in four models (UV-K, UV-X, UV-Y, UV-Z) and is intended for use in hospitals, clinics, and households under physician direction on intact skin only.

The device uses LED light sources rather than the predicate's xenon-chlorine excimer lamp, but maintains the same 308nm±2nm UVB wavelength. Key differences include maximum power output (30-50 mW/cm² vs predicate's 50 mW/cm²), treatment area (3-3.41 cm² vs predicate's 16 cm²), treatment time (1-140 seconds vs predicate's 1-40 seconds), and power source options including lithium battery capability. Display is OLED rather than non-publicly available on predicate.

Safety and performance testing per IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-57, IEC 60601-2-83, and IEC 62471. Biocompatibility testing per ISO 10993-5 (cytotoxicity), ISO 10993-10 (sensitization), and ISO 10993-23 (irritation). Software documentation per FDA guidance on device software functions.

The subject device and predicate device share identical intended use (treating the same five skin conditions on intact skin) and both use LED UVB light sources at 308nm wavelength applied as handheld, reusable, prescription-use treatments in similar environments. Although the subject device differs in LED architecture, power output levels, treatment area size, and battery options, these differences do not raise new safety or effectiveness concerns because the fundamental technology and treatment mechanism remain substantially equivalent. Biocompatibility and electrical safety testing confirm the device meets applicable standards without introducing new risks.