faceLITE is proud to announce that its handLITE™ device has received FDA clearance (K250224), becoming the world’s first non-UV light therapy device approved for the treatment of irritant contact dermatitis (ICD) of the hand.
This marks a significant breakthrough for the faceLITE brand and further reinforces our position as a leader in LED-based skincare and wellness innovation. It follows the recent FDA clearance of our décolletage wrinkle treatment device, underlining our ongoing commitment to creating safe, effective, and clinically proven light-based therapies for real-world conditions.
Hand dermatitis remains a widespread and challenging issue, affecting hundreds of millions of people globally each year. According to 2025 data, chronic cases are estimated to impact around 376 million adults annually. Women are particularly affected, often due to repeated exposure to irritants in both domestic and workplace settings. Existing treatments typically involve long-term use of steroid creams or immunomodulators, which can come with side effects and adherence challenges. Until now, there were no FDA-cleared non-UV light therapy options available for managing this condition.
handLITE™ uses clinically validated red (630nm) and near-infrared (830nm) wavelengths to deliver targeted, non-invasive photobiomodulation therapy.
In a controlled clinical crossover study, the handLITE device delivered impressive results:
- 96% of participants saw an improvement in dermatitis severity after the first treatment course
- Over 50% of users reported their dermatitis had greatly improved, almost cleared or completely cleared
- 76% reported a reduction in itchiness (pruritus)
- Crucially, no adverse events were reported – supporting the device’s excellent safety profile and suitability for home use
Sue D’Arcy, CEO and Founder of faceLITE’s parent company, iSMART Developments commented:
“This latest FDA clearance is a huge milestone for the entire team. It reflects our mission to develop advanced, non-invasive therapies that offer meaningful alternatives to traditional treatments.
With handLITE, we’re giving people an effective and safe solution for managing dermatitis – one that avoids the complications often linked to steroids or immunosuppressants. As we build on the success of our décolletage wrinkle clearance, we remain committed to shaping the future of light-based wellness through robust clinical research."
This new FDA clearance not only provides a powerful at-home solution for those living with hand dermatitis, but also opens up exciting partnership opportunities with pharmaceutical companies and innovation teams looking to expand into evidence-backed LED therapy.
faceLITE continues to redefine the possibilities of light therapy, with more consumer-friendly and clinically validated devices already in development.
