Ulthera, 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
Ulthera® System510(k)May 21, 2026General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	May 21, 2026
Ulthera System (UC-1 Control Unit PRIME Model 2.1)510(k)May 13, 2025General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	May 13, 2025
Ulthera® System510(k)Feb 24, 2025General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	Feb 24, 2025
Ulthera System (UC-1 Control Unit PRIME)510(k)Feb 22, 2024General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Special)	Feb 22, 2024