Aerin Medical, Inc. FDA Approvals

0 new drug approvals and 4 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
RhinAer+ Stylus510(k)May 18, 2026General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	May 18, 2026
Aerin Console510(k)Dec 10, 2024General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	Dec 10, 2024
Reach Needle510(k)Mar 21, 2024Anesthesiology	Anesthesiology	510(k)Substantially Equivalent (Traditional)	Mar 21, 2024
RhinAer® Stylus (FG1393)510(k)Jul 29, 2022General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Special)	Jul 29, 2022