Third Party Testing & Certification
Manufacturing Process
Device Certifications
Underwriters Laboratories Certification
Vital Red Light devices have passed rigorous safety testing conducted by Underwriters Laboratories (UL), a leading global safety certification company. Our products meet IEC 60601 standards for medical electrical equipment, ensuring they are safe for use in both home and professional environments.
UL is recognized as the gold standard for safety in the U.S., with strict protocols for testing, evaluating, and certifying electronic products.
FDA Medical Device Certification
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.
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 Laboratories Certification
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.
This certification ensures our devices conform to multiple parts of the IEC 60601 standard, which governs the safety, performance, and reliability of medical electrical equipment.
- IEC 60601-1: General requirements for basic safety and essential performance.
- IEC 60601-1-2: Standards for electromagnetic compatibility.
IEC 60601-1-6: Requirements for usability. - IEC 60601-1-11: Requirements for medical electrical equipment used in the home healthcare environment.
- IEC 60601-2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring, and cosmetic/aesthetic use.
- IEC 60601-2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment.
UKCA Medical Device Certification
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. It’s a mark of approval that indicates a product operates within specified parameters and doesn’t interfere with other electronic devices.
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 Device Certification
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.
Federal Communications Commission’s Certification
Canada Health registration: Shenzhen Idea Light devices and wearable products are registered as Class II medical devices with the Health Canada(HC), indicating they meet specific safety and efficacy standards for therapeutic use.
MDL Class II Medical Device.
Restriction of Hazardous Substances Certification
RoHS certification, or Restriction of Hazardous Substances certification, is a regulation that limits the use of hazardous materials in electrical and electronic equipment (EEE).
IEC 62321-4:2013 + A1:2017 – Describes the use of four test methods for mercury in polymers, metals and electronics, namely CV-AAS (cold vapour atomic absorption spectrometry), CV-AFS (cold vapour atomic fluorescence spectrometry) ICP-OES (inductively coupled plasma optical.
Standards Association of Australia Certification
Shenzhen Idea Light products comply with Australian/New Zealand electrical safety standards + certification by an Australian accredited body
SAA electrical safety standards certification
13485 Medical Device Quality Management System Certification
Shenzhen Idea Light products have passed the quality management system standards for the medical device industry set by the International Organization for Standardization (ISO)
ISO 13485 Class II Medical Device.
