RightEye, LLC was issued a Warning Letter from the FDA due to “the RightEye Vision System was cleared under K181771 with the following indications: “recording, viewing, and analyzing eye movements in support of identifying visual tracking impairment in human subjects.” However, your firm’s promotion of the device provides evidence that the device is intended to improve vision problems and measure and analyze eye movements for the broader genre of “neurological disorders,” including Parkinson’s disease, which would constitute a major change or modification to its intended use for which your firm lacks clearance or approval.” For more information, see the link below.
