Cleared Traditional

K233104 - SofWave System (FDA 510(k) Clearance)

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

K233104 · Sofwave Medical, Ltd. · General & Plastic Surgery device
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Dec 2023
Decision
87d
Days
Class 2
Risk

K233104 is an FDA 510(k) clearance for the SofWave System. Classified as Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption (product code OHV), Class II - Special Controls.

Submitted by Sofwave Medical, Ltd. (Yokneam Iiit, IL). The FDA issued a Cleared decision on December 22, 2023 after a review of 87 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 Sofwave Medical, Ltd. devices

Submission Details

510(k) Number K233104 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2023
Decision Date December 22, 2023
Days to Decision 87 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 114d · This submission: 87d
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 K233104.
Ulthera System (UC-1 Control Unit PRIME Model 2.1)
K250418 · Ulthera, Inc. · May 2025
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
K232455 · Sofwave Medical, Ltd. · Dec 2023
SCIZER (SC1-M410)
K230100 · Classys, Inc. · Nov 2023