Phototherapy System (DUV-COMBO)

The DUV-COMBO Phototherapy System is an LED-based ultraviolet light device for professional dermatological treatment. It delivers narrow-band UVA (360–390 nm, peak 371.3 nm) and UVB (300–320 nm, peak 308.8 nm) radiation via two separate handpieces to treat skin conditions including psoriasis, vitiligo, atopic dermatitis, seborrheic dermatitis, and leukoderma.

Both the DUV-COMBO and predicate device (Psoria-Shield AURORA) use LED technology with dual-channel architecture, digital touchscreen control, and keylock safety mechanisms. Key differences include operating system (Windows CE 6.0 vs. Linux Ubuntu), physical dimensions (19"×15"×38" vs. 19"×14"×8"), weight (46 lbs vs. 12 lbs), and treatment areas (1.7–42.0 cm² vs. 2.88 cm²). Maximum energy density outputs are identical at 3.4 J/cm².

IEC 60601-1:2005/AMD1:2012, IEC 60601-2-57:2023, IEC 60601-1-6:2010/AMD2:2020, IEC 60601-1-2:2014+AMD1:2020, CISPR 11:2016+AMD2:2019, IEC 61000 series, IEC 62471:2006, ISO 10993-1:2018, IEC 62304:2015, and FDA guidance on medical device software.

The DUV-COMBO is substantially equivalent because it shares fundamental technological characteristics with the predicate device—both employ LED-based narrow-band UV delivery for dermatological phototherapy with identical maximum dose outputs and safety mechanisms. Design differences (operating system, dimensions, weight, treatment areas) are non-critical and do not affect safety or effectiveness. Comprehensive nonclinical testing confirms compliance with applicable safety and performance standards, and a reference device (K181805) demonstrates that larger treatment areas are within the established performance range of legally marketed devices.