ViOptix, Inc. 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
Lap.Ox Laparoscopic Tissue Oximeter510(k)Jun 26, 2025Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Jun 26, 2025
Intra.Ox 2.0 Handheld Tissue Oximeter510(k)Feb 28, 2024Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Feb 28, 2024
Intra.Ox 2.0 Handheld Tissue Oximeter510(k)May 3, 2022Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Special)	May 3, 2022