Optos Plc. 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
P200TE (A10700)510(k)May 9, 2024Ophthalmic	Ophthalmic	510(k)Substantially Equivalent (Traditional)	May 9, 2024
P200TE (A10700)510(k)Aug 18, 2023Ophthalmic	Ophthalmic	510(k)Substantially Equivalent (Traditional)	Aug 18, 2023