3rd December 2024

Breaking New Ground: iSMART Developments Secures FDA Clearance for Décolletage Wrinkle Treatment

UK-based skincare, aesthetic and medical device innovator iSMART Developments has announced a major breakthrough with FDA 510(k) clearance of its décoLITE LED device, making it the first in the world cleared for wrinkle treatment specifically targeting the décolletage area.

This clearance is a game-changer for the aesthetic device market, as décoLITE offers a clinically proven, non-invasive solution to a concern often overlooked in traditional skincare. The device utilises red and near-infrared light to reduce wrinkles and pigmentation through a process called photobiomodulation. In a six-week clinical trial, 84% of participants reported visible improvements in skin texture, pigmentation, and wrinkle depth.

The milestone FDA clearance further establishes iSMART as a leader in light-based anti-ageing technology. With its flexible, wearable design, décoLITE is set to redefine skincare convenience and efficacy for consumers worldwide.

As the device rolls out in the US under its new OHS classification, iSMART is preparing to set a new standard in at-home skin rejuvenation.

If you’re interested in partnering with iSMART – please get in touch with us.