Ulthera System (UC-1 Control Unit PRIME Model 2.1)— 510(k) K250418

Name: FDA 510(k) clearance K250418
Creator: U.S. Food and Drug Administration
Published: 2025-05-13

Substantially Equivalent

Ulthera, Inc.

FDA 510(k) clearance K250418 for Ulthera System (UC-1 Control Unit PRIME Model 2.1), Substantially Equivalent on 2025-05-13. Applicant: Ulthera, Inc.. Device class: 2.

Clearance details

Applicant: Ulthera, Inc.
Product code: Code OHV
Device class: Class 2
Regulation: 21 CFR 878.4590
Advisory panel: General, Plastic Surgery
Date received: 2025-02-13
Decision date: 2025-05-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Raleigh, NC, US

Download summary PDF View on FDA.gov ↗

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