OEM / ODM · ISO 13485 Manufacturing

Light therapy devices, engineered for your brand.

From optical architecture to certified mass production. LUXEN builds medical-grade red light therapy systems for beauty, clinical and wellness brands in more than 40 markets — with your name on the housing and our engineering underneath it.

ISO 13485 FDA-registered facility CE · UKCA · TGA 120+ patents
633 NM 830 NM FLEXIBLE PCB · 66 LED ZONES
48h Sample turnaround
on catalogue models
50+R&D engineers across optics, electronics and firmware
120+Patent certificates in optical and thermal architecture
40+Export markets served from our Shenzhen facility
12Production lines with in-house SMT and ageing test
What We Do

One partner from first drawing to first shipment

Most brands assemble a supply chain: an ID studio, a tooling shop, an electronics house, a certification lab. We keep those four under one roof so specifications stop drifting between vendors.

Optical engineering

Wavelength stacks, lens design and irradiance mapping held inside ±5% across the treatment area.

Thermal & structure

Heat paths and ergonomics co-designed, validated over a full 20-minute session rather than a 60-second peak.

App & IoT

BLE/Wi-Fi firmware and brand-owned app UI, with dose tracking and session scheduling built in.

Compliance

Pre-compliance testing and documentation support for FDA, CE, UKCA, TGA and MDL routes.

How a Programme Runs

Five stages, fixed review gates

Each gate has a deliverable and a sign-off. Nothing moves forward on optimism.

01

Brief & feasibility

Dose targets, market and compliance route reviewed against our platforms.

02

Design & simulation

Optical and thermal simulation, ID and CMF confirmation.

03

Prototype

Functional units tested for output, heat and control stability.

04

Certification

Pre-compliance testing, then third-party certification on request.

05

Production

Trial run, first-article inspection, then scheduled mass production.

Research & Development

Feasibility before aesthetics

Fifty engineers, 120+ patents and a verification-first workflow. We design around biological mechanism and delivered dose — so the performance you claim can be defended in a regulatory review.

±5%

Output uniformity across the treatment area

IEC 60601

Verification baseline for every prototype

Read the R&D approach
StageDeliverable
ConceptProduct definition and dose spec
SimulationOptical + thermal model
PrototypeFunctional units, bench data
VerificationPre-compliance test report
ProductionTooling, FAI, scale-up
OEM / ODM

Your brand on the housing. Our engineering underneath.

Low MOQ sampling, custom wavelengths, and a compliance route mapped before tooling starts.