Oculus Optikgeräte GmbH 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
Pentacam® Cornea OCT510(k)Mar 13, 2026Ophthalmic	Ophthalmic	510(k)Substantially Equivalent (Traditional)	Mar 13, 2026
Myopia Master510(k)Jul 14, 2021Ophthalmic	Ophthalmic	510(k)Substantially Equivalent (Traditional)	Jul 14, 2021