UV Phototherapy Device (Group A: SQ308PCHFD, SQ308PCQFD, SQ308PCPFD, SQ308PCNFD, SQ308PCMFD); UV Phototherapy Device (Group B: SQ308PHTFF, SQ308PHSFF, SQ308PHRFF, SQ308PHZFG, SQ308PPUFF, SQ308PPVFF, SQ308PPWFG)

This is a UV phototherapy device for treating psoriasis, vitiligo, and atopic dermatitis (eczema) on intact skin. Patients use it at home under physician guidance, with a controller that regulates LED light emission time based on a preset dose, stopping automatically when the set dose is reached.

The device has a peak wavelength of 308nm with slight variations from predicates (280–320nm range). Max irradiation power ranges from 27–486mW across models, treatment areas are (30±2)×(30±2)mm or (45±2)×(45±2)mm, and radiation intensity is ±20%–50%±20%. Maximum dosage is limited to 5 J/cm². Minor differences in output specifications, treatment area, and treatment time exist compared to predicates, but all remain within acceptable ranges.

IEC 60601-1:2005+AMD1:2012+AMD2:2020, IEC 60601-1-2:2014, IEC 60601-1-11:2015, IEC 60601-2-57:2011, IEC 60601-2-83:2019+A1:2022, ISO 10993-5, ISO 10993-10, and ISO 10993-23 for electrical safety, performance, biocompatibility, and home light therapy equipment requirements.

The proposed device has identical indications for use and mode of operation as predicate devices (K223882, K191571, K170489, K040062/K090097, K200971). While minor differences exist in wavelength, irradiation power, treatment area, and output specifications, these differences do not raise safety or effectiveness concerns because all specifications comply with the same IEC standards and remain within or comparable to predicate device ranges. Non-clinical testing confirms the device meets design specifications and performs equivalently to predicates.