handLITE (TN19S)

The handLITE (TN19S) is a wearable LED phototherapy device in the form of a flexible silicone glove that emits red (630nm) and near-infrared (830nm) light. It is intended to treat dermatological conditions, specifically contact dermatitis of the hand and wrist, and is used at home by lay users for 10-minute treatment sessions at an intensity of 30mW/cm².

The handLITE uses red and near-infrared LEDs (same as faceLITE predicate) rather than blue light (different from Philips BlueControl). It delivers 18J/cm² per treatment with a 10-minute session duration, shorter than BlueControl's 30 minutes. Treatment protocol is 5 times weekly for 6 weeks (30 total treatments), fewer than BlueControl's 52 treatments over 12 weeks. The device uses a flexible silicone glove housing with integrated lithium-ion battery and timer-controlled software.

IEC 60601-1:2005, IEC 60601-1-2:2014, IEC 60601-1-11:2015, IEC 60601-2-57:2011, IEC 60601-2-83:2019, IEC 62133-2:2017 for electrical safety and home healthcare use; IEC 62471:2006 for photobiological eye safety; IEC 62366-1:2015 for usability and label comprehension testing.

The handLITE shares the same generic classification (Class II laser surgical instrument per 21 CFR 878.4810), product code (ONE), and intended use (light-based dermatological therapy) as both predicates. Although it uses different wavelengths than BlueControl, it matches faceLITE's red/near-infrared spectrum and intensity. Clinical testing demonstrated efficacy (mean SCORAD improvement of 12.2 for treated hand vs. 3.5 for control) with no adverse events, and human factors testing confirmed usability. The device employs identical LED technology and home-use wearable format as the predicates, with differences in treatment duration and dosage representing minor modifications that do not affect the fundamental therapeutic principle.