faceLITE PRO has received US Food and Drug Administration (FDA) 510(k) clearance for the treatment of full-face wrinkles, marking an important regulatory milestone for faceLITE and iSMART Developments.
The clearance, issued under 510(k) number K260598, covers the five-wavelength LED facemask developed by iSMART Developments for over-the-counter home use.
What does FDA clearance mean for faceLITE PRO?
Under the 510(k) process, the FDA determined that the device is substantially equivalent to a legally marketed predicate device for its stated indication. For faceLITE PRO, that cleared indication is specifically the treatment of full-face wrinkles.
That distinction matters: FDA clearance relates to the stated wrinkle-treatment indication. Other visible skin benefits associated with faceLITE PRO are supported by separate clinical-study data rather than by the FDA-cleared indication.
Five wavelengths in one at-home LED treatment
The FDA-cleared device combines five red and near-infrared wavelengths:
- 610 nm red light
- 630 nm red light
- 660 nm red light
- 850 nm near-infrared light
- 1070 nm near-infrared light
The flexible silicone mask is designed for home use and operates as one straightforward programme. Each treatment lasts 10 minutes, after which the device switches off automatically.
How does this fit with the faceLITE PRO clinical study?
Alongside its FDA clearance, faceLITE PRO has been evaluated in a 12-week US clinical study involving 24 adults. Participants used the mask for 10 minutes, five times per week.
The study found that 79% of participants achieved at least a one-grade improvement in facial wrinkles. It also reported improvements in under-eye dark circles, pigmentation and erythema, providing a broader evidence base for the five-wavelength treatment.
These broader findings are valuable, but they should be considered separately from the FDA-cleared indication, which remains treatment of full-face wrinkles.
A new regulatory milestone in faceLITE's LED heritage
The team behind faceLITE has more than 25 years of experience in medical, professional and consumer light therapy. FDA clearance for faceLITE PRO builds on that heritage while bringing five-wavelength LED technology into a flexible, wearable home-use format.
For consumers researching an FDA-cleared LED face mask for wrinkles, faceLITE PRO combines regulatory clearance, a simple 10-minute programme, and separate 12-week clinical evidence in a single at-home device.
Explore faceLITE PRO and its five-wavelength LED technology.
