What kind of safety testing have you done on the iRestore device?

We have performed rigorous QA and tests to ensure the safety and efficacy of our devices meet the highest international standards. Our device manufacturing processes conform to ISO standards and certified to be compliant by Intertek Testing Services. Here are the certifications we hold to show our commitment to our customers' safety:

  • IEC 60601-1 (Safety)
  • IEC 60601-1-2 (EMC)
  • IEC 60825 (Safety of laser products)
  • ISO 10993 (Biological evaluation of medical devices)
  • GMP-certified manufacturing partner (Good Manufacturing Practice)

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