Revolutionizing Wellness: High-Tech Precision Meets Superior Quality

Discover the Luxxe Advantage: Precision-Crafted Quality in Every Device
Excellence in Engineering: Our devices are meticulously engineered and manufactured in a facility certified under ISO 13485 and MDSAP standards, ensuring the highest levels of quality, safety, and regulatory compliance in every product we deliver.

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Luxxe’s FDA Position & Commitment to Quality

General Wellness Classification
Luxxe devices are categorized as low-risk, general wellness products. These do not require FDA clearance or approval because they do not claim to diagnose, treat, or cure medical conditions. According to FDA guidelines, wellness devices that support muscle relaxation, circulation, and overall well-being can be marketed without regulatory approval, provided they do not make medical claims.
Manufacturing Excellence
While FDA approval isn’t required, Luxxe is built to medical-grade standards in MDSAP and ISO-certified facilities. We use precision LED drivers and premium components to ensure long-term reliability and safety.
Transparency Over Hype

Some brands use FDA Class II registration as a marketing tactic—implying approval or superiority. Luxxe chooses science, compliance, and clarity over gimmicks.

Science-Backed Protocols

Luxxe protocols are based on peer-reviewed, full-body clinical studies. Our dosing and session settings follow research-backed standards—no guesswork needed. Reference studies are available for full transparency.

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At Luxxe, we have elevated the technology that goes into the basic design of light therapy panel systems. By adding innovative functionality not seen before, we’ve created a new paradigm in delivering therapeutic benefits. Our approach removes the guesswork, ensuring precision, safety, and efficacy in every session, setting a new standard for light therapy. Guaranteed.
Frequently Asked Questions

Is Luxxe FDA-approved?

No. Luxxe is a general wellness device, not intended to diagnose or treat medical conditions, so FDA approval isn’t required.

Why isn’t there an FDA registration number?

FDA registration ≠ approval. Some brands register for marketing. Luxxe focuses on science, compliance, and real results.

How do I know Luxxe is safe and effective?

Luxxe is built in certified facilities (MDSAP, ISO, FDA-compliant) and follows protocols from full-body clinical studies—with references available.

Our Commitment to You
“Luxxe is committed to science, safety, and effectiveness. We stay aligned with the latest research in full-body red and near-infrared light therapy to ensure our protocols match clinical studies. Our goal is to deliver precise, automated, and straightforward light therapy, free from misleading marketing or regulatory ambiguity.
By maintaining full compliance and prioritizing transparency, Luxxe leads in both quality and research-driven innovation.

Smart Detection. Precision Dosing. Perfectly Tailored

Therapeutic-Range IR Detection – Aligned with your body’s natural absorption window Scientifically Proven & Safe – Used in medical and wellness applications globally Effortless Precision – Adapts to your position for the perfect session every time At Luxxe, we didn’t just add a sensor—we over-engineered it to work in perfect harmony with our dosing intelligence. Because true precision isn’t just smart—it’s essential for real results.

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Luxxe’s patent-pending Smart Distance Detection technology ensures the optimal red and near-infrared light therapy dose—effortlessly adapting whether you’re standing, sitting, or lying down.

Our advanced 904nm infrared sensor operates within the same therapeutic light range as Luxxe’s own red and near-infrared LEDs—proving that even our detection system works in harmony with your wellness goals.

But the sensor is just part of the equation. It works in concert with Luxxe’s proprietary software, which continuously senses your precise distance, applies the inverse square law, and dynamically adjusts LED output in real time—maintaining the target power at your current distance. The system detects your position and adapts instantly to keep dosing precise.

The result? Each protocol delivers the exact power and session time modeled after published clinical trials—no charts, no calculations, just true research-backed dosing.

Unlike traditional narrow-beam sensors that require precise placement, Luxxe’s wide-field detection system seamlessly tracks your position and automatically adjusts output—delivering precision without the hassle.

Luxxe’s Devices Are Engineered and Manufactured to the Highest Quality, with World-Class Electrical and Internal Components.

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The factory we commissioned was chosen for its ISO 13485 and MDSAP accreditation, ensuring it meets the rigorous standards set by the International Organization for Standardization (ISO) and the Medical Device Single Audit Program (MDSAP).

This level of certification reflects exceptional quality management, regulatory compliance, and precision manufacturing, aligning with Luxxe’s commitment to safety, reliability, and industry-leading technology.

Engineered for Excellence

OWN YOUR LUXXE
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Every Luxxe device is manufactured in a world-class facility that meets the most rigorous global standards in medical device quality, safety, and performance. Our manufacturing partner is certified under:
  • MDSAP (Medical Device Single Audit Program)
  • ISO 13485 (Medical Device Quality Management)
  • FDA QSR (21 CFR Part 820)
  • TGA (Australia), MDL (Canada), and UKCA (UK) Compliance
  • CE and RoHS (Europe)
  • UL & ETL IEC 60601 Safety Standards
  • Global-Mark and SAI Global certification bodies
This means each device is built under strict protocols for risk management, design validation, and regulatory compliance—and is supported by extensive documentation and safety testing. From our medical-grade components to our non-contact, flicker-free, low nnEMF design, Luxxe goes beyond the industry standard to deliver intelligent, research-backed red light therapy that’s not only effective and effortless, but built to outperform and outlast. We don’t just build light therapy panels—we engineer precision medical-grade technology for a new era of wellness.