FDA-Cleared LED Therapy
Our FDA-cleared 4D mask makes clinical LED light therapy effortless at home — calibrated wavelengths, professional-grade engineering, and results that build with consistent use.
Know You Better, Work Better
The Story Behind Your Glow
In 2015, founder Robert's battle with severe acne revealed a gap in skincare: the need for professional-grade solutions gentle enough for home use. A clunky light therapy mask inspired his bold idea — redefining effective, accessible skincare.
2016–2024: Your Feedback Built Our Future
We didn't just make products — we listened, learned, and evolved with you.
The First Eye Mask
You paired our mask with gel patches — so we created the first eye mask for comfort.
A Head-Hugging Fit
“Too heavy.” We redesigned the mask for a head-hugging fit.
Pressure, Relieved
“Still presses on my eyes.” We widened the straps and added cushioning to reduce pressure.
Weight Off Your Eyes
“What if the pressure shifted?” Using biomechanics, we floated the weight on the forehead instead of the eyes.
FDA Clearance & Flagship Launch
Our flagship 4D LED Face Mask received FDA clearance for treating full-face wrinkles with red (650nm) light and mild-to-moderate inflammatory acne with blue (465nm) light.
Zero Discomfort — NEWKEY Face Pro
The ultimate challenge: zero discomfort. The breakthrough? NEWKEY Face Pro, crafted from medical-grade silicone, eliminated every pinch and pressure point.
Your Voice, Our Obsession
Our mission remains: fuse cutting-edge tech with care you can feel. Because skincare isn't just about light — it's about listening to the people under it.
Where Science Meets Skincare
Every NEWKEY device is engineered and tested against IEC 60601 electrical-safety, IEC 62471 photobiological-safety, and ISO 10993 biocompatibility standards.
Calibrated Wavelength Engineering
Every wavelength is calibrated to its specification in every unit — the 4D mask emits red 650nm and blue 465nm light — the wavelengths cleared by the FDA.
Safety & Compliance Testing
Devices are tested to IEC 60601, IEC 62471, and ISO 10993 — biocompatibility, electrical and photobiological safety.
Safety Engineering
Every device undergoes 200+ quality checkpoints. Our hypoallergenic materials are biocompatibility-tested to strict ISO 10993 standards.
Regulatory Compliance
FDA-cleared as a Class II OTC medical device for home use.
Our Core Values
Clinical Integrity
We never compromise on wavelength accuracy. Every claim stays inside our FDA clearance and verified specifications.
Human-Centric Design
Luxury comfort is not an afterthought. Our devices are engineered to feel as good as they perform.
Relentless Innovation
We invest continuously in R&D to make phototherapy more effective, more comfortable, and easier to use at home.
Accessible Excellence
Professional phototherapy should not require a clinic visit — we bring FDA-cleared technology home.
World-Class Expertise
Our product, quality, and regulatory teams keep every claim inside the FDA clearance.
Regulatory & Clinical Affairs
FDA Clearance Submission
Class II OTC device · 21 CFR 878.4810
Photobiology Engineering
Optical Design
Red 650nm + Blue 465nm · IEC 62471 photobiological safety
Quality & Biocompatibility
Materials & Safety
ISO 10993-1 / -5 / -10 · IEC 60601 electrical safety
Design & Ergonomics
Industrial Design
4D contour fit · lightweight ABS+PC shell with silicone eye cover
Ready to Transform Your Skin?
Discover FDA-cleared LED light therapy at home. 2-year warranty. 90-day money-back guarantee.