Evolution Optiks Receives US FDA 510(k) Clearance for Tele-refactor

Barbados-based Evolution Optiks announced June 4 that it had received 510(k) clearance from the US FDA for the LFR-260, its light field powered subjective tele-refractor.

The device gained CE marking in Europe in March 2024.

The fully digital LFR-260 features QuadView, which shows up to four slightly different prescriptions simultaneously, with no lenses or wall chart required. Evolution Optiks says the compact, portable device can be operated remotely from anywhere in the world, which makes it ideal for telemedicine.

The FDA created a new product category to differentiate the device from traditional Class I manual refractors, which are 510(k) exempt.