iSMART Developments’ handLITE™ has received FDA clearance (K250224) as the world’s first non-UV light therapy device indicated for the treatment of irritant contact dermatitis.
This milestone cements iSMART's position at the forefront of LED therapy innovation, following closely behind the recent clearance of the world's first light therapy device for the treatment of wrinkles in the décolletage area. Both achievements showcase the company's continued commitment to pioneering safe, effective, and clinically proven solutions for unmet medical needs.
Dermatitis of the hand remains a significant challenge, affecting millions worldwide and frequently limiting day-to-day activities. Traditional treatments often involve the long-term use of topical steroids or immunomodulators, both of which are associated with side effects and patient compliance issues. Until now, there have been no FDA-cleared non-UV light therapy devices available for treating this condition.
The handLITE device harnesses the power of clinically validated red (630nm) and near-infrared (830nm) wavelengths to deliver targeted photobiomodulation therapy.
A controlled clinical crossover study demonstrated that treatment with handLITE resulted in statistically significant reductions in dermatitis severity. After the first treatment course 96% of subjects reported that their dermatitis had improved from baseline with over half of the study group indicating that their dermatitis had improved greatly, almost cleared or completely cleared, with 76% reporting improvements in pruritic. Importantly, no adverse events were reported, reinforcing the device’s strong safety profile and suitability for convenient at-home use.
Sue D'Arcy, CEO and Founder of iSMART Developments, commented, "This latest FDA clearance marks another major milestone for the team at iSMART. It underscores our commitment to developing advanced, non-invasive therapies that fill real gaps in the market. Our handLITE device offers a highly effective alternative for patients seeking to manage their dermatitis without the risks associated with steroidal or immunosuppressive treatments. Building on the success of our décolletage wrinkle treatment clearance, we are proud to continue shaping the future of LED-based healthcare solutions through clinical research."
The FDA clearance of handLITE for dermatitis not only opens new avenues for patients but also signals an important opportunity for pharmaceutical partners and new product development teams seeking innovative, evidence-backed therapies.
iSMART Developments continues to lead the way in advancing phototherapy beyond more traditional UV-based models, with a robust pipeline of future innovations already underway.