Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Ulthera System (UC-1 Control Unit PRIME Model 2.1)

K-Number: K250418 · 2025-05-13

ApplicantUlthera, Inc.
Decision Date2025-05-13
Product CodeOHV
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Ulthera System (UC-1 Control Unit PRIME Model 2.1) is a medical device manufactured by Ulthera, Inc.. It received FDA 510(k) clearance on 2025-05-13 under approval number K250418. 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 (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. It is manufactured by Ulthera, Inc.. The 510(k) number is K250418.

When was Ulthera System (UC-1 Control Unit PRIME Model 2.1) approved by the FDA?

Ulthera System (UC-1 Control Unit PRIME Model 2.1) received FDA 510(k) clearance on 2025-05-13, under approval number K250418.

What company makes Ulthera System (UC-1 Control Unit PRIME Model 2.1)?

Ulthera System (UC-1 Control Unit PRIME Model 2.1) is manufactured by Ulthera, Inc..

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.

Related Clinical Trials

NCT07614997 Effectiveness and Safety of the Ulthera® System for Skin Laxity in the Lower Face, Submentum and Neck NOT_YET_RECRUITING NCT06727942 Virtual Reality-Infused Treadmill Training on Aging-Related Outcomes RECRUITING NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT03053791 Deep Brain Stimulation in Patients With Incomplete Spinal Cord Injury for Improvement of Gait RECRUITING NCT05174312 Fluid Management of Acute Decompensated Heart Failure Subjects Treated With Reprieve Decongestion Management System (DMS) COMPLETED NCT07039942 French Prospective Multicentric Study in Real World RECRUITING

Related PubMed Literature

PMID: 40624055 Establishment of a clinical workflow for in vivo Raman spectroscopy during head and neck cancer surgery. Scientific reports (2025)

Other Devices by Ulthera, Inc.

K161885The Cellfina System K153677The Cellfina System K180623Ulthera System K192185The Cellfina System K233996Ulthera System (UC-1 Control Unit PRIME) K243035Ulthera® System

View all 7 devices →

Related Devices (Code: OHV)

K162163UltraShape SystemSyneron Medical, Ltd. K161952UltraShape SystemSyneron Medical, Ltd. K160896ULTRASHAPE POWER SYSTEMSyneron Medical, Ltd. K170370ULTRASHAPE POWER SYSTEMSyneron Medical, Ltd. K180623Ulthera SystemUlthera, Inc. K181896LIPOcelJeisys Medical, Inc.

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.

↑