Cleared Traditional

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

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K250418 · Ulthera, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2025
Decision
89d
Days
Class 2
Risk

K250418 is an FDA 510(k) clearance for the Ulthera System (UC-1 Control Unit PRIME Model 2.1). Classified as Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption (product code OHV), Class II - Special Controls.

Submitted by Ulthera, Inc. (Raleigh, US). The FDA issued a Cleared decision on May 13, 2025 after a review of 89 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4590 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ulthera, Inc. devices

Submission Details

510(k) Number K250418 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 2025
Decision Date May 13, 2025
Days to Decision 89 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 114d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OHV Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4590
Definition A Device Using Focused Ultrasound To Produce Localized, Mechanical Motion Within Tissues And Cells For The Purpose Of Producing Either Localized Heating For Tissue Coagulation Or For Mechanical Cellular Membrane Disruption Intended For Non-invasive Aesthetic Use.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - OHV Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption

All 28
Devices cleared under the same product code (OHV) and FDA review panel - the closest regulatory comparables to K250418.
Ulthera® System
K243035 · Ulthera, Inc. · Feb 2025
SofWave System
K240687 · Sofwave Medical, Ltd. · May 2024
Ulthera System (UC-1 Control Unit PRIME)
K233996 · Ulthera, Inc. · Feb 2024
SofWave System
K233104 · Sofwave Medical, Ltd. · Dec 2023
SofWave System
K232455 · Sofwave Medical, Ltd. · Dec 2023
SCIZER (SC1-M410)
K230100 · Classys, Inc. · Nov 2023