Infrascan, 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
Infrascanner Model 2500 (Model 2500)510(k)Dec 12, 2024Ophthalmic	Ophthalmic	510(k)Substantially Equivalent (Traditional)	Dec 12, 2024
Infrascanner510(k)Feb 9, 2022Ophthalmic	Ophthalmic	510(k)Substantially Equivalent (Traditional)	Feb 9, 2022