Kandyway Red Light Therapy Mask Testing & Certification
We believe that extensive testing and certifications shows how much a manufacturer cares about its customers.
Here are all the tests our device has passed to ensure the safety and efficacy of our device.
Feel confident knowing that you will be using are the most tested red light therapy mask in the world.
| NORTH AMERICA | |
| FDA-cleared | for wrinkle reduction and anti-aging |
| Health Canada-authorized | for wrinkle reduction, anti-aging and inflammation |
| US: ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 | Safety & effectiveness of medical electrical equipment |
| IEC 60601-1-2 Edition 4.1 2020-09 | EMC – Medical devices |
| IEC 60601-2-57:2011 | Medical equipment safety for light devices |
| US: IEC 60601-1-11 Edition 2.1 2020-07 | Basic safety & electrical performance of medical electrical equipment |
| US: IEC 60601-2-83:2020 | Basic safety and essential performance of home light therapy equipment |
| US : EC 60601-1-6:2010+A1:2013+A2:2020 | Medical Electrical Usability |
| US : IEC62471 :2006 | Eye Safety |
| IEC 62133-2:2017 | Battery Safety |
| IEC 60529:1989+AMD1:1999+AMD2:2013 | IP Testing |
| ISO 10993-1:2018 | Biocompatibility |
| US & EU : ISO 10993-5:2009, 10993-10:2002 | Biocompatibility |
| ISTA-1A:2014/ISTA-3A :2018 | Performance of packaging |
| EUROPEAN UNION | |
| EN 60601-1:2006/A12:2014 Medical electrical equipment | General requirements for basic safety and essential performance. |
| EN 60601-1-2:2015 Medical electrical equipment | General requirements for basic safety and essential performance. Collateral standard. Electromagnetic compatibility. Requirements and tests |
| IEC 60601-1-6 2010 AMD1: 2013 Medical Electrical Equipment – Part 1 | General Requirements for Basic Safety and Essential Performance – Collateral Standard: Usability. |
| IEC/EN60601-1-11:2015 Medical electrical equipment -- Part 1-11 | General requirements for basic safety and essential performance -- Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment |
| IEC/EN 60601-2-57:2011 Medical electrical equipment | Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring, and cosmetic/aesthetic use |
| EN 62471:2008 | Photobiological Safety of Lamps and Lamp Systems |
| EN 62366-1:2015 | Application of usability engineering to medical devices. |
| EN ISO 10993-1:2018 Biological evaluation of medical devices Part 1: | Evaluation and testing within a risk management process |
| EN ISO 15223-1:2021 Medical Devices | Symbols to be used with information to be supplied by the manufacturer |
| EN ISO 14971:2012 Medical devices | Application of risk management to medical devices |
| IEC62133:2012 2nd edition | Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells and batteries made from them for use in portable applications |
| BS EN 55014-1: 2021 Electromagnetic compatibility | Requirements for household appliances, electric tools, and similar apparatus |
| BS EN 55014-2:2015 Electromagnetic compatibility | Requirements for household appliances, electric tools, and similar apparatus. Immunity. Product family standard |
| (REACH) directive(EC 1907/2006) | Registration, Evaluation, Authorization, and Restriction of Chemicals |
