Aeye Health, Inc. FDA Approvals

0 new drug approvals and 2 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
AEYE-DS510(k)Apr 23, 2024Ophthalmic	Ophthalmic	510(k)Substantially Equivalent (Traditional)	Apr 23, 2024
AEYE-DS510(k)Nov 10, 2022Ophthalmic	Ophthalmic	510(k)Substantially Equivalent (Traditional)	Nov 10, 2022