Product Certifications
Each of our devices undergoes extensive testing and registration to meet the highest international standards of safety, performance, and quality.
These certifications demonstrate our commitment to producing reliable, effective, and compliant LED light therapy devices that you can trust.
Why Our Certifications Matter
Certifications are more than logos — they’re independent proof that our products are safe, effective, and ethically manufactured. Each standard listed below verifies a specific aspect of quality, from electrical safety and medical efficacy to environmental compliance.
Our Global Certifications Explained
CE (European Conformity)
The CE mark indicates that our devices conform to European Union safety, health, and environmental protection standards, allowing them to be legally sold across Europe.
UKCA (UK Conformity Assessed)
Confirms that our products comply with the United Kingdom’s medical device and safety regulations, equivalent to CE certification within the UK market.
FCC (Federal Communications Commission)
Shows that our electronic devices meet U.S. standards for radio frequency and electromagnetic compatibility, ensuring they operate safely and do not interfere with other electronics.
RoHS (Restriction of Hazardous Substances)
Verifies that our products are free from hazardous materials such as lead, mercury, and cadmium. RoHS compliance ensures our devices are environmentally friendly and safe for long-term use.
FDA (U.S. Food & Drug Administration)
Indicates that our devices are registered with the U.S. FDA as Class II medical devices, meeting strict requirements for safety, efficacy, and therapeutic performance in medical and wellness applications.
FDA 510(k)
This certification confirms that our products have been cleared by the FDA through the 510(k) process, meaning they are substantially equivalent to legally marketed medical devices and comply with all U.S. medical device regulations.
TGA (Therapeutic Goods Administration, Australia)
Indicates that our devices are registered as Class II medical devices with Australia’s TGA, meeting national standards for safety, effectiveness, and quality in therapeutic use.
MDSAP (Medical Device Single Audit Program)
Demonstrates that our manufacturing system has been audited and approved across multiple global markets (including the USA, Canada, Australia, Japan, and Brazil), reflecting exceptional quality assurance practices.
ETL Intertek (Electrical Testing Laboratories)
A North American safety certification issued by Intertek, verifying that our devices comply with applicable U.S. and Canadian electrical safety standards, similar to UL certification.
ISO 13485 (Medical Device Quality Management System)
An internationally recognised certification showing that our manufacturer follows a strict quality management system specific to medical devices, ensuring consistent manufacturing and product reliability.
Global Mark
An Australian certification body that validates compliance with electrical safety, performance, and quality standards for products sold globally, ensuring safe and consistent operation.
Our Commitment to Quality and Compliance
At LED Light Therapy Shop, we partner only with certified manufacturers and continually update our compliance to align with global safety and medical device standards.
These certifications ensure every product you purchase is safe, effective, and built with integrity.
Written and reviewed by LED Light Therapy Shop October 2025 – Specialists in FDA-cleared blue, red, and near-infrared LED light therapy devices.
