iSMART Secures FDA Clearance for Non-UV LED Device in Treatment of Hand Dermatitis

iSMART Developments has announced that its handLITE™ device has received FDA clearance (K250224) as the world’s first non-UV light therapy device indicated for the treatment of irritant contact dermatitis (ICD) of the hand.

This clearance further establishes iSMART Developments as a leader in LED therapy innovation, following its recent FDA clearance for the first light therapy device indicated for the treatment of wrinkles in the décolletage area. These milestones demonstrate the company's ongoing focus on developing safe, effective, and clinically validated solutions for unmet medical needs.

Hand dermatitis remains a widespread condition, affecting millions globally and often impairing daily activities. Traditional treatment options typically involve long-term use of topical steroids or immunomodulators, both of which carry risks of side effects and adherence challenges. Until now, no FDA-cleared non-UV light therapy devices had been available for this indication.

The handLITE™ device utilises clinically validated red (630 nm) and near-infrared (830 nm) wavelengths to deliver targeted photobiomodulation therapy.

In a controlled clinical crossover study, treatment with handLITE™ resulted in statistically significant reductions in dermatitis severity. After the first course of treatment, 96% of subjects reported improvement from baseline, with more than half indicating that their dermatitis had improved greatly, almost cleared, or completely cleared. Additionally, 76% of participants reported improvements in pruritus. No adverse events were reported during the study, supporting the device’s strong safety profile and its 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."