iSMART Secures FDA 510(k) Clearance for decoLITE

iSMART Developments innovative LED device, décoLITE, is the first and only FDA 510(k)-cleared product specifically indicated for the treatment of wrinkles in the décolletage area. This FDA clearance cements iSMART Developments' position as a leader in advanced, non-invasive anti-ageing technologies.

The décoLITE device harnesses the power of red and near-infrared light through photobiomodulation, a non-thermal mechanism that stimulates and rejuvenates skin at the cellular level. Designed for convenient home use, the lightweight and flexible device is worn comfortably over the décolletage area and delivers noticeable results within six weeks of use. Clinical trials demonstrated that 84% of participants saw improvements in the appearance of décolletage wrinkles, an observation concurred by 2 blinded dermatologists who evaluated images from the study group.

“We’re proud to lead innovation in the light-based skincare sector,” said Sue D’Arcy, CEO of iSMART Developments. “Our FDA 510(k) clearance for décoLITE not only validates our technology but also marks a significant advancement in aesthetic treatments for the décolletage, a previously underserved area.”

As part of the FDA clearance process, iSMART Developments met rigorous clinical and safety testing requirements, positioning décoLITE as a gold-standard solution in non-invasive wrinkle treatments.

This achievement also highlights iSMART's commitment to regulatory excellence and patient safety. The company’s focus now turns to broadening global availability in other territories.

For more information, please visit www.ismart.health.