Optim, LLC 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
ENTity USB Videoscope System510(k)May 14, 2026Ear, Nose, Throat	Ear, Nose, Throat	510(k)Substantially Equivalent (Traditional)	May 14, 2026
ENTity WiFi Video Nasopharyngoscope System510(k)Jan 13, 2021Ear, Nose, Throat	Ear, Nose, Throat	510(k)Substantially Equivalent (Traditional)	Jan 13, 2021