US Regulatory Status

  • 1. EyeCalm has been reviewed in accordance with section 513(g) of The Federal Food Drug and Cosmetic Act (Act).
  • 2. EyeCalm is regarded as a medical device as defined in section 201(h).
  • 3. EyeCalm meets the definition of a stand-alone software-only medical device as well as a software-as-a-medical device as it is a server based software application accessible via a web browser.