Ulthera® System
K-Number: K243035 · 2025-02-24
ApplicantUlthera, Inc.
Decision Date2025-02-24
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 2025-02-24 under approval number K243035. 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 2025-02-24. It is manufactured by Ulthera, Inc.. The 510(k) number is K243035.
When was Ulthera® System approved by the FDA?
Ulthera® System received FDA 510(k) clearance on 2025-02-24, under approval number K243035.
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.