Certifications & Testing

Our Commitment to Quality and Safety

Our Rigorous Testing Protocol

Beyond certifications, our products undergo a stringent in-house and third-party testing regimen throughout the production cycle

These certifications and our rigorous testing protocols are a testament to our dedication to your well-being. They are the foundation of the trust our partners place in us and the confidence you can have in every IdeaLight device.
1

Design Validation & Verification

Ensuring the product design meets user needs and regulatory requirements from the outset.

2

Component Sourcing & Inspection

We use only high-grade, medical-quality components from vetted suppliers, with every batch inspected upon arrival.

3

In-Line Production Testing

Critical parameters like optical output (wavelength and irradiance), electrical safety, and build quality are checked at every stage of assembly.

4

Finished Product Audit

Every single unit undergoes a final functional test to verify performance, stability, and safety before packaging.

5

Reliability & Lifespan Testing

We conduct accelerated life testing on samples to ensure long-term reliability and validate the rated lifespan of our LEDs and electronic systems.

At Shenzhen Idea Light Limited, our commitment to excellence is not just a promise—it's a standard that is rigorously verified and validated. Every device we manufacture is subjected to a multi-layered testing process and must meet the world's most stringent international certifications for safety, performance, and quality management.

Our certifications are your assurance that you are investing in a medical-grade product built with integrity, precision, and an unwavering focus on user safety.

Our Quality Management Foundation

ISO 13485:2016 & MDSAP (Medical Device Single Audit Program)These are the cornerstones of our quality system.ISO 13485certifies that we adhere to a comprehensive quality management system specifically for the design and manufacture of medical devices. Our participation inMDSAPmeans our system has been audited and accepted by multiple international regulatory authorities (including the US FDA, Health Canada, and Australia's TGA), demonstrating a globally recognized standard of excellence.

Global Market Access & Regulatory Approvals

We ensure our products meet the specific regulatory requirements of markets around the world, facilitating a smooth entry for our partners.

🇺🇸 USA: FDA 510(k) Clearance

Our key therapeutic devices have received FDA 510(k) clearance, signifying that they are legally marketed in the United States and are recognized as safe and effective for their intended use.

🇦🇺 Australia: TGA Approval

Our products comply with the Therapeutic Goods Administration's strict standards for medical devices in Australia.

🇨🇦 Canada: Medical Device License (MDL)

We hold the necessary Medical Device Licenses from Health Canada, confirming our products meet the country's safety and efficacy requirements.

Underwriters Laboratories Certification

UL Certification: Idea Light Generation 3.0&4.0 devices and wearable products have undergone rigorous testing by third-party and bear the safety certification mark of UL.
UL is the most authoritative safety testing company in the United States. It focuses on testing, evaluating and certifying product safety.

FDA Medical DeviceCertification

FDA Registration: Shenzhen Idea Light devices and wearable products are registered as Class II medical devices with the U.S. Food and Drug Administration (FDA), indicating they meet specific safety and efficacy standards for therapeutic use.
FDA Class II Medical Device.

510K Medical DeviceCertification

Shenzhen Idea Light mask products are registered with the U.S. Food and Drug Administration (510K) as Class II medical devices, indicating that they meet specific safety and effectiveness standards for treatment
510k Class II Medical Device.

MDSAP Medical System Certification

ISO 13485 & MDSAP: Idea Light complies with ISO 13485 & MDSAP, an internationally recognized standard for quality management systems specific to the medical device industry.
MDSAP Medical System

Electrical Testing LaboratoriesCertification

ETL certification, or the ETL Listed Mark, is a product safety certification that indicates a product meets North American safety standards. ETL stands for Electrical Testing Laboratories, and the certification is issued by Intertek, an international certification organization.
Idea Light devices conform to multiple parts of the IEC 60601 series

UKCA Medical DeviceCertification

The UKCA medical certificate is issued by a notified body (Approved Bodies) recognized by the British government, proving that the medical device product complies with the UK Medical Device Regulations.
UKCA Class II Medical Device.

Federal Communications Commission’s Certification

FCC certification is a mandatory requirement in the United States that ensures electronic devices meet the Federal Communications Commission’s (FCC) standards for radio frequency interference and electromagnetic compatibility.
All measurements contained in this report were conducted with CISPR 16-1. radio disturbance andimmunity measuring apparatus, and CISPR16-2, Method ofmeasurement of disturbances andimmunity

TGA Medical DeviceCertification

The Therapeutic Goods Administration (TGA) registration: Shenzhen Idea Light devices and wearable products are registered as Class II medical devices with the Therapeutic Goods Administration(TGA) in Asutralia, indicating they meet specific safety and efficacy standards for therapeutic use.
TGA Class II Medical Device.