Icare Finland OY FDA Approvals

0 new drug approvals and 3 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
iCare ST500 (TA04)510(k)Sep 27, 2024Ophthalmic	Ophthalmic	510(k)Substantially Equivalent (Traditional)	Sep 27, 2024
iCare IC200510(k)Oct 6, 2022Ophthalmic	Ophthalmic	510(k)Substantially Equivalent (Traditional)	Oct 6, 2022
iCare HOME2510(k)Jan 25, 2022Ophthalmic	Ophthalmic	510(k)Substantially Equivalent (Traditional)	Jan 25, 2022