Cleared Traditional

K223237 - SofWave System (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence.

K223237 · Sofwave Medical, Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2022
Decision
58d
Days
Class 2
Risk

K223237 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 16, 2022 after a review of 58 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 K223237 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 2022
Decision Date December 16, 2022
Days to Decision 58 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
56d faster than avg
Panel avg: 114d · This submission: 58d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Consultant

Hogan Lovells US LLP
Janice M. Hogan

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Clinical Evidence

ClinicalTrials.gov
NCT05358847 Completed Interventional Industry-sponsored

Treatment for Cellulite Appearance

Safety and Efficacy of Sofwave Treatment for Improvement of Cellulite Appearance

69
Patients (actual)
4
Sites
Treatment
Purpose
Open label
Masking
Condition studied Cellulite
Study design Single group
Eligibility Female only · 18 Years+ · Healthy volunteers accepted
Sponsor Sofwave Medical LTD (industry)
Started 2021-11-21 → Primary completion 2023-03-01
Primary outcome
Rate of improvement in the appearance of cellulite on the upper thigh/buttock area
Study completed - no results published. This trial concluded in 2023 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov

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 K223237.
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
K233104 · Sofwave Medical, Ltd. · Dec 2023
SofWave System
K232455 · Sofwave Medical, Ltd. · Dec 2023