Ulthera System (UC-1 Control Unit PRIME Model 2.1)
K-Number: K250418 · 2025-05-13
Device Summary
Frequently Asked Questions
What is the Ulthera System (UC-1 Control Unit PRIME Model 2.1)?
Ulthera System (UC-1 Control Unit PRIME Model 2.1) is a medical device that received FDA 510(k) clearance on 2025-05-13. The listed applicant is Ulthera, Inc.. The 510(k) number is K250418.
When did Ulthera System (UC-1 Control Unit PRIME Model 2.1) receive FDA 510(k) clearance?
Ulthera System (UC-1 Control Unit PRIME Model 2.1) received FDA 510(k) clearance on 2025-05-13, under 510(k) number K250418.
Who is the listed applicant for Ulthera System (UC-1 Control Unit PRIME Model 2.1)?
The FDA 510(k) record lists Ulthera, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Ulthera System (UC-1 Control Unit PRIME Model 2.1)?
The FDA product code for Ulthera System (UC-1 Control Unit PRIME Model 2.1) is OHV.
Other records listing Ulthera, Inc. as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Related Devices (Code: OHV)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
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.