FDA-Cleared LED Therapy for Every Home
We make FDA-cleared LED light therapy effortless at home — calibrated wavelengths, professional-grade engineering, and results that build with consistent use.
From Lab Bench to Your Vanity
The Spark
Founded by engineers and skincare enthusiasts who believed LED phototherapy should be accessible at home.
Built on Standards
Engineering and testing infrastructure aligned to IEC 60601 electrical safety, IEC 62471 photobiological safety, and ISO 10993 biocompatibility.
FDA Clearance & Flagship Launch
Our flagship 4D LED Face Mask received FDA 510(k) clearance (K230351) for treating full-face wrinkles with red (650nm) light and mild-to-moderate inflammatory acne with blue (465nm) light.
Trusted Worldwide
A growing community of at-home users makes NEWKEY part of their daily LED light therapy ritual.
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
Each of the 7 wavelengths is calibrated to its clinical specification in every unit — red 650nm, blue 465nm and beyond.
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 510(k)-cleared as a Class II OTC medical device (K230351) 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 510(k) clearance (K230351).
Regulatory & Clinical Affairs
FDA 510(k) Submission
Class II OTC device · K230351 · 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.