Regulatory Compliance

Aetheia has achieved the following regulatory compliance for the standards shown below, allowing it to be marketed in the geographies specified.

This website is for educational and informational purposes only, and is not intended as medical advice or a substitute for medical advice.

Aetheia is intended for non-invasive examination, illumination, magnification, visualisation and recording of digital photographs and video of the anterior segment for all geographies, and in all non-US geographies, posterior eye segments of the human eye and its surrounding area.

UK (UKCA)

Aetheia is registered with the MHRA (Medicines and Healthcare products Regulatory Agency) as a Class I medical device under the requirements of UK MDR 2002.

Europe (CE Marking)

Classified as a Class I device, Aetheia has been assessed and meets the General Safety and Performance Requirements under the MDR 2017/745.

The device can be sold into the 27 countries across the EU plus Northern Ireland, Iceland, Liechtenstein and Norway.

United States (FDA Listing)

Aetheia is a Class II, 510(k) exempt device that is intended for the non-invasive examination, dose-limited illumination (in accordance with ANSI Z80.36), magnification and visualisation of the anterior segment of the human eye. Listed under the FDA PUE product code, which is the 510(k) exempt code for slit lamps.

Aetheia does not provide quantitative output and is not used for screening or automated diagnostic indications. It is also limited to an examination of the anterior portion of the eye. The PUE code does not cover posterior segment examination so Aetheia is not available in the US for that purpose.