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Medical-Grade Engineering

Engineering-Driven R&D for Light Therapy Devices

Fifty specialised engineers, 120+ patents, and a verification-first workflow. We run partner-led OEM/ODM programmes and our own platforms on one discipline: measurable optical output, controlled thermal behaviour, and documentation that survives regulatory review.

630 × 300 MM ACTIVE AREA 660 NM · RED 850 NM · NIR IRRADIANCE ±5%
±5% Output tolerance
across the panel
Our R&D Approach

Feasibility before aesthetics.

Research at LUXEN is judged by whether a device can be built, measured and defended — not by how the render looks.

Every programme follows a fixed engineering sequence in which optical accuracy, thermal management and the evidence required by FDA, TGA, MDL, UL, CE and UKCA are entry conditions rather than optional add-ons. If a concept cannot be verified at the end of the line, we say so at the start.

The result is a shorter distance between a brand’s idea and a medical-grade product: one team owns the optics, the electronics, the housing, the software and the paperwork that prove all four work together.

Our method is risk-based and clinically oriented. Consumer devices are typically designed around feature marketing and basic safety testing; we design around biological mechanism, delivered dose and medical-level risk control — so the performance a brand claims can be substantiated, not merely advertised.

120+

Patent certificates, and still filing

Accumulated across optical architecture, thermal design and wearable ergonomics. Each filing answers a specific engineering problem — wavelength mixing, heat extraction inside a sealed mask, stable output over a 20-minute session.

  • Optical & dosimetry patents
  • Thermal management patents
  • Wearable structure & ergonomics
  • Control firmware & app logic
Before the first call

Five inputs that shorten feasibility review

You do not need a finished specification. Sharing these five points lets our engineers return a real roadmap instead of a brochure.

Submit Your Requirements
  • Form factor — mask, panel, belt, handheld or a targeted applicator.
  • Wavelength concept — 630/660 nm, 810/850 nm, blue, or a combination you have in mind.
  • Target market — the compliance route follows the market, not the other way round.
  • Dose expectation — session length, irradiance and treatment area.
  • Brand experience — housing CMF, packaging direction, app or no app.

No NDA required for an initial review. If your project needs one, we will sign yours.

Two-Track R&D Model

Partner programmes and our own platforms, one engineering standard

Whether we are building your product or our next catalogue model, the same verification logic, the same test benches and the same review gates apply.

Partner-Led OEM / ODM

We take a partner’s industrial design, dose targets and market requirements, then return a device that can be verified, certified and produced at volume. Your brand stays on the housing; our engineering sits underneath it.

  • Design-for-manufacture review at concept stage
  • Optical simulation before tooling
  • Pre-compliance testing in-house

LUXEN In-House Innovation

Our own team keeps developing market-ready platforms, applying the newest optical and control architectures so partners can start from a tested base instead of a blank sheet — and shorten time-to-market by months.

  • Catalogue platforms available for immediate wholesale
  • New wavelengths piloted on our own models first
  • Firmware and app maintained in-house
From Concept to Feasible Specifications

Three engineering disciplines, one device

Early concepts become measurable specifications through review, simulation and bench work. Most of our value sits in configurations that standard moulds cannot reach.

Optical Engineering

Custom wavelength stacks — red 630/660 nm, NIR 810/850 nm, blue, yellow and blue-violet — with irradiance held inside a narrow band across the whole treatment area, not just at the centre point.

Smart Integration & App

Firmware, BLE/Wi-Fi modules and app development in-house: session scheduling, dose tracking and a UI that carries your brand rather than a generic white-label shell.

Structural & Thermal

Heat paths, airflow and ergonomics solved together. Sustained-output testing over a full session replaces the peak-number claims that collapse after ten minutes of use.

From Concept to Certified Product

What each stage actually delivers

Our R&D headcount grew from 40 to 50+ engineers as programmes multiplied. The team stays on one project from the first sketch to the first article inspection, so nothing is lost in a handover.

StageWhat we deliver
Concept creationProduct definition aligned to brand positioning, target market and dose requirements
Concept to visualisationIndustrial design and photoreal renders matched to the final CMF and manufacturing route
PrototypingFunctional prototypes for optical, thermal and usability validation — not appearance models
Test reports & certificatesPre-compliance testing and documentation support for FDA 510(k), MDL, TGA, CE, UKCA and IEC 60601
Trial productionPilot runs on production tooling with first-article inspection before scale-up
Consumer-Grade vs Medical-Grade

“Medical-grade” is a system, not a sticker

In light therapy, the label is not defined by one certificate, nor by whether a device is sold to hospitals. It describes how a product is designed, validated, produced and controlled across its whole lifecycle.

DimensionConsumer-grade devicesLUXEN medical-grade approach
Design logicFeature-drivenRisk-based, clinically oriented
Performance claimsMarketing-ledEvidence-based, traceable to test data
SafetyBasic safety testingMedical-level risk management
Product lifecycleShort, model replaced yearlyLong-term stability and traceability

In practice, that means four things a buyer can audit: efficacy, compliance, consistency and traceability.

Quality dimensionWhat LUXEN delivers
EfficacyOutput grounded in biological mechanism and delivered-dose calculation
Regulatory complianceAligned with MDSAP and ISO 13485 frameworks across target markets
ConsistencyRepeatable output from controlled, validated processes — unit to unit, batch to batch
TraceabilitySystematic risk identification, batch records and long-term stability data
Medical capability is no longer a feature brands add at the end. It is what decides whether a brand can stay in a regulated market at all.
Verification

Prototype, Testing & Verification

Before a single tool is cut, prototypes are measured on four axes: output consistency, thermal behaviour, control stability and user safety. Results are compared against IEC 60601, FDA, UL, MDL, CE, UKCA and TGA requirements, and gaps are closed on the bench rather than discovered at certification.

Compliance by design — regulatory risk removed early, when it is still cheap to remove.

Manufacturability

Engineering for Manufacturing

A design that cannot be reproduced is not a design. R&D outputs are reviewed against ISO 13485 process capability, assembly tolerance and test coverage from the first drawing, so the transition from bench to line is a scheduled step rather than a rescue operation.

One drawing set, one bill of materials, one owner — from lab to production line.

What We Develop

Form factors where optical control decides the outcome

We concentrate on devices where wearability, output stability and system reliability are the difference between a product and a novelty.

WEARABLE · FLEXIBLE PCB
Wearable

LED Red Light Facial Masks

Programmes built for professional beauty use, with R&D focused on optical layout, comfort over a 20-minute session, and output that does not drift as the mask warms up.

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PANEL · ALUMINIUM CORE
Full Body

Red Light Panels

High-output panel concepts for professional and clinic-oriented use, engineered around output uniformity, heat extraction and the reliability expected from equipment that runs daily.

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TARGETED · LOCALISED DOSE
Targeted

Eye & Targeted Devices

Localised light delivery for specific treatment areas, extending an existing platform through controlled optics and a housing tuned to the application rather than the category average.

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PROFESSIONAL · SYSTEM LEVEL
Professional

PDT-Related Devices

Light systems for photodynamic concepts and professional treatment scenarios, where R&D addresses controlled output, integration with the wider system and customisation feasibility.

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Next Step

Ready to engineer your hero product?

You should not have to choose between custom and proven. Our R&D platform gives you both — a tailored device built on architecture we have already validated.

Quick Instant Quote

Tell us the device. We’ll tell you what it takes.

Send your requirements and an engineer — not a sales script — will reply with a feasibility note, a tooling estimate and a realistic timeline. Low MOQ sampling available.

  • Reply within one business day
  • NDA signed on request before drawings are shared
  • Feasibility note at no cost

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