Amo Manufacturing USA, LLC 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
Catalys Precision Laser System510(k)Apr 12, 2023Ophthalmic	Ophthalmic	510(k)Substantially Equivalent (Traditional)	Apr 12, 2023
CATALYS Precision Laser system510(k)May 17, 2022Ophthalmic	Ophthalmic	510(k)Substantially Equivalent (Traditional)	May 17, 2022
CATALYS Precision Laser System510(k)Apr 7, 2021Ophthalmic	Ophthalmic	510(k)Substantially Equivalent (Special)	Apr 7, 2021