Pearl, Inc. FDA Approvals

0 new drug approvals and 8 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
Second Opinion® Panoramic510(k)Nov 14, 2025Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Nov 14, 2025
Second Opinion® CS510(k)Jun 12, 2025Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jun 12, 2025
Second Opinion® 3D510(k)May 23, 2025Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	May 23, 2025
Second Opinion® BLE510(k)May 9, 2025Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	May 9, 2025
Second Opinion® Pediatric510(k)May 5, 2025Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	May 5, 2025
Second Opinion Periapical Radiolucency Contours510(k)Apr 11, 2025Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Apr 11, 2025
Second Opinion CC510(k)Jan 16, 2025Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jan 16, 2025
Second Opinion510(k)Mar 4, 2022Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Mar 4, 2022