Phelcom Technologies 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
Eyer 2510(k)Jan 16, 2026Ophthalmic	Ophthalmic	510(k)Substantially Equivalent (Traditional)	Jan 16, 2026
Eyer Retinal Camera NM-STD510(k)Feb 22, 2023Ophthalmic	Ophthalmic	510(k)Substantially Equivalent (Traditional)	Feb 22, 2023