In a word, Yes!
To be more specific:
REVIAN was cleared by the United States Food and Drug Administration (FDA) under 510(k) #K173729 in 2018 according to the federal standards for safety and electromagnetic compatibility
REVIAN has been independently evaluated and confirmed to conform to the following safety standards:
- ANSI/AAMI/ISO 10993-1 2009/(R)2013 – Biological Evaluation of Medical Devices
- ANSI/AAMI ES60601-1:2005/(R)2012 – Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and Essential Performance
- ANSI/AAMI/IEC 60601-1-2:2014 – Medical Electrical Equipment – General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests.
- IEC 60601-2-57 – 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.
- IEC 62471 Ed. 1.0 – Photobiological safety of lamps and lamp systems.
- IEC 62133-2 Ed. 1.0 – Secondary cells and batteries containing alkaline or other non-acid electrolytes – Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications – Part 2: lithium systems