Ulthera, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Ulthera, Inc. - FDA 510(k) Cleared Devices
Recent clearances: Ulthera® System, Ulthera System (UC-1 Control Unit PRIME Model 2.1), Ulthera® System
14
Total
13
Cleared
1
Denied
Ulthera, Inc. has 13 FDA 510(k) cleared general & plastic surgery devices. Based in Mesa, US.
Latest FDA clearance: May 2026. Active since 2009.
Browse the complete list of FDA 510(k) cleared general & plastic surgery devices from this manufacturer. Filter by specialty or product code using the sidebar.
1 device has linked clinical trial registered on ClinicalTrials.gov.
FDA 510(k) Regulatory Record - Ulthera, Inc.
14 devices
Cleared
May 21, 2026
Ulthera® System
General & Plastic Surgery
85d
Cleared
May 13, 2025
Ulthera System (UC-1 Control Unit PRIME Model 2.1)
General & Plastic Surgery
89d
Cleared
Feb 24, 2025
Ulthera® System
General & Plastic Surgery
150d
Cleared
Feb 22, 2024
Ulthera System (UC-1 Control Unit PRIME)
General & Plastic Surgery
66d
Cleared
CT
Oct 09, 2019
The Cellfina System
General & Plastic Surgery
58d
Cleared
May 04, 2018
Ulthera System
General & Plastic Surgery
56d
Cleared
Oct 05, 2016
The Cellfina System
General & Plastic Surgery
86d
Cleared
Feb 25, 2016
The Cellfina System
General & Plastic Surgery
66d
Cleared
Jul 29, 2015
Cellfina System
General & Plastic Surgery
154d
Cleared
Jun 20, 2014
ULTHERA SYSTEM
General & Plastic Surgery
171d
Cleared
Dec 11, 2013
ULTHERA SYSTEM
General & Plastic Surgery
163d
Cleared
Oct 02, 2012
ULTHERA SYSTEM
General & Plastic Surgery
117d