Ulthera System
K-Number: K180623 · 2018-05-04
ApplicantUlthera, Inc.
Decision Date2018-05-04
Product CodeOHV
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Ulthera System is a medical device manufactured by Ulthera, Inc.. It received FDA 510(k) clearance on 2018-05-04 under approval number K180623. The device is classified under product code OHV. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Ulthera System?
Ulthera System is a medical device that received FDA 510(k) clearance on 2018-05-04. It is manufactured by Ulthera, Inc.. The 510(k) number is K180623.
When was Ulthera System approved by the FDA?
Ulthera System received FDA 510(k) clearance on 2018-05-04, under approval number K180623.
What company makes Ulthera System?
Ulthera System is manufactured by Ulthera, Inc..
What is the FDA product code for Ulthera System?
The FDA product code for Ulthera System is OHV.
Related Clinical Trials
Other Devices by Ulthera, Inc.
Related Devices (Code: OHV)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.