Premier North America, Inc. FDA Approvals

0 new drug approvals and 5 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
NUNA LUX (NUNL528)510(k)Mar 1, 2024General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	Mar 1, 2024
BLU TOTALE (Model: ENEOB852)510(k)Nov 14, 2023General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	Nov 14, 2023
Avologi Gel Primer (Model: Av25)510(k)Sep 15, 2023Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Sep 15, 2023
Luminice510(k)Feb 24, 2022Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Feb 24, 2022
ENEO TOTALE (Model: ENEOT947)510(k)Jan 6, 2022General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Special)	Jan 6, 2022