Medical Device Manufacturer · US , Mesa , AZ

Ulthera, Inc. - FDA 510(k) Cleared Devices

14 submissions · 13 cleared · Since 2009

Recent clearances: Ulthera® System, Ulthera System (UC-1 Control Unit PRIME Model 2.1), Ulthera® System

14
Total
13
Cleared
1
Denied

FDA 510(k) Regulatory Record - Ulthera, Inc. General & Plastic Surgery ✕

14 devices
1-12 of 14
Cleared May 21, 2026
Ulthera® System
K260618 · OHV
General & Plastic Surgery · 85d
Cleared May 13, 2025
Ulthera System (UC-1 Control Unit PRIME Model 2.1)
K250418 · OHV
General & Plastic Surgery · 89d
Cleared Feb 24, 2025
Ulthera® System
K243035 · OHV
General & Plastic Surgery · 150d
Cleared Feb 22, 2024
Ulthera System (UC-1 Control Unit PRIME)
K233996 · OHV
General & Plastic Surgery · 66d
Cleared CT Oct 09, 2019
The Cellfina System
K192185 · OUP
General & Plastic Surgery · 58d
Cleared May 04, 2018
Ulthera System
K180623 · OHV
General & Plastic Surgery · 56d
Cleared Oct 05, 2016
The Cellfina System
K161885 · OUP
General & Plastic Surgery · 86d
Cleared Feb 25, 2016
The Cellfina System
K153677 · OUP
General & Plastic Surgery · 66d
Cleared Jul 29, 2015
Cellfina System
K150505 · OUP
General & Plastic Surgery · 154d
Cleared Jun 20, 2014
ULTHERA SYSTEM
K134032 · OHV
General & Plastic Surgery · 171d
Cleared Dec 11, 2013
ULTHERA SYSTEM
K132028 · OHV
General & Plastic Surgery · 163d
Cleared Oct 02, 2012
ULTHERA SYSTEM
K121700 · OHV
General & Plastic Surgery · 117d
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