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Ulthera Inc

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
13
Inspections
4
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0749-2017Class IICellfina Prep Pack, Part No. CP1November 14, 2016

Recent 510(k) Clearances

K-NumberDeviceDate
K250418Ulthera System (UC-1 Control Unit PRIME Model 2.1)May 13, 2025
K243035Ulthera® SystemFebruary 24, 2025
K233996Ulthera System (UC-1 Control Unit PRIME)February 22, 2024
K192185The Cellfina SystemOctober 9, 2019
K180623Ulthera SystemMay 4, 2018
K161885The Cellfina SystemOctober 5, 2016
K153677The Cellfina SystemFebruary 25, 2016
K150505Cellfina SystemJuly 29, 2015
K134032ULTHERA SYSTEMJune 20, 2014
K132028ULTHERA SYSTEMDecember 11, 2013
K121700ULTHERA SYSTEMOctober 2, 2012
K122528ULTHERA SYSTEMAugust 28, 2012
DEN080006ULTHERA SYSTEM, MODEL 8850-0001September 11, 2009