Certified. Tested. Trusted.
Every Luxen device is engineered to meet — and exceed — the world's most rigorous safety and quality standards.
Your Safety Is Not a Marketing Claim.
Red light therapy is an investment in your wellness — and you deserve to know exactly what you're bringing into your home. That's why every Luxen device is tested, audited, and certified by independent international regulatory bodies before it ever reaches you.
Below is a complete list of the certifications, standards, and quality systems behind every product we ship.
FDA Registered Facility
Luxen devices are manufactured in a facility registered with the United States Food and Drug Administration. The facility is subject to FDA inspection and oversight.
What it means for you
Your device is produced in a controlled, FDA-supervised environment that meets U.S. manufacturing standards.
FCC Certified
Luxen wireless devices comply with Part 15 of FCC regulations. Electromagnetic emissions are tested and verified within safe limits.
What it means for you
Safe to use alongside your phone, Wi-Fi, and other household electronics.
UKCA Marked
The UKCA mark confirms Luxen devices meet UK safety, health, and environmental protection requirements — the UK's post-Brexit conformity standard.
What it means for you
Approved for sale and use across Great Britain under strict consumer-protection standards.
TGA Listed
Luxen devices are listed with Australia's Therapeutic Goods Administration, the regulatory body responsible for the safety and quality of therapeutic products sold in Australia.
What it means for you
Authorised for sale in Australia as a low-risk therapeutic device.
CE Marked
The CE mark is Europe's harmonised conformity marking, indicating Luxen devices meet EU health, safety, and environmental protection standards.
What it means for you
Legal for sale across the EU and EEA, certified against rigorous European consumer-safety directives.
RoHS Compliant
Luxen products comply with the Restriction of Hazardous Substances Directive — manufactured without lead, mercury, cadmium, or other restricted materials.
What it means for you
Free from toxic substances commonly found in lower-quality electronics — safer for your home and the planet.
ISO 13485 Certified Manufacturing
ISO 13485 is the international quality management standard designed specifically for medical device manufacturers. Luxen's manufacturing partner operates a documented, audited quality management system at every stage — from design and sourcing to assembly and post-market surveillance.
What it means for you
The same quality-control framework used by hospital-grade medical device makers worldwide.
1Tested Once Isn't Tested Enough.
Certification is a starting point — not a finish line. In addition to the international standards above, every Luxen device passes through three internal quality checks before leaving our facility:
- Pre-Production Testing — Each new batch is sampled and tested for wavelength accuracy (±5nm tolerance) and irradiance output.
- In-Line Inspection — LEDs, drivers, and electrical components are individually verified during assembly.
- Final QA & Burn-In — Every finished unit runs through a continuous power-on test to detect early failures before packaging.
2If We're Wrong, We Make It Right.
Every Luxen device is covered by a 2-year warranty against manufacturing defects and a 60-day money-back guarantee. If your device doesn't meet the standards you'd expect from a brand built around safety and quality, contact our team — we'll repair, replace, or refund.
3Need a Specific Certificate?
If you require a copy of a specific certification for compliance, salon licensing, or insurance purposes, our team is happy to share it. Email us with the certificate name and your device model, and we'll send the documentation within 2 business days.
Contact Support →For any questions about our certifications or quality standards, contact us at support@luxenredlight.com.