SofWave System
by Sofwave Medical Ltd Israel EUDAMED510(k)
510(k) K230019
Product code OHV
Overview
The SofWave System is a Focused Ultrasound Device for Tissue Heat or Mechanical Cellular Disruption, classified under Device Class II (OHV product code). It employs focused ultrasound technology to deliver precise, non-invasive energy to targeted tissues, enabling controlled thermal or mechanical effects for therapeutic or cosmetic applications in general and plastic surgery.
This system is supplied as a traditionally cleared medical device under FDA 510(k) and MDD regulations. It is intended for single-use applications, with no indication of MRI compatibility or reusable components. The device operates within a controlled clinical setting and requires adherence to manufacturer guidelines for storage and handling. Authorisations include FDA clearance (K230019) and EU MDD compliance, with registration numbers and FEI codes listed for regulatory tracking.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK230019 | Date14 Mar 2023 | StatusActive |
| European Union | CE/MDD EUDAMED | Number— | Date— | StatusActive |
Coverage
- Active
- Expiring (legacy directive)
- Not covered
- European Union
- United States
Specification
- 510(k) Number
- FDA Product Code
- OHV
- FDA applicant
- Sofwave Medical, Ltd.
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4590
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Other devices from Sofwave Medical Ltd
Questions
What types of procedures is the SofWave System designed to assist with, and in which clinical settings is it used?
The SofWave System is a focused ultrasound device intended for controlled thermal or mechanical effects on targeted tissues, primarily used in general and plastic surgery applications. It is designed for non-invasive procedures where precise energy delivery is required, such as therapeutic or cosmetic interventions. The device operates exclusively in controlled clinical settings, adhering to manufacturer guidelines for safe and effective use.
Is the SofWave System intended for single-use or repeated use, and what does this mean for maintenance and replacement?
The SofWave System is explicitly designed for single-use applications only. This means each device is intended to be used once and then discarded, eliminating the need for cleaning, sterilization, or maintenance between procedures. Clinicians should follow manufacturer instructions for proper disposal to ensure patient safety and compliance.
What regulatory pathways has the SofWave System undergone, and how does this affect its availability in different markets?
The SofWave System has received FDA clearance under the 510(k) pathway (K230019) and complies with the EU Medical Device Directive (MDD). This means it is legally authorized for use in the United States and the European Economic Area, though specific market access may depend on additional local requirements. The device’s classification as Class II (OHV product code) reflects its moderate risk level and regulatory oversight.
How should the SofWave System be stored, and are there any special handling requirements to maintain its performance?
The SofWave System requires adherence to manufacturer-provided guidelines for storage and handling to ensure optimal performance and sterility. Since it is single-use, proper storage conditions—such as temperature, humidity, and protection from contamination—are critical before use. Clinicians should refer to the device documentation for detailed storage instructions to prevent degradation or compromise of its functionality.
Does the SofWave System come with multiple models or sizes, and if so, how do these vary for different clinical applications?
The SofWave System includes multiple FEI (Final Equipment Identification) numbers, indicating the existence of several distinct models or configurations. These variations likely cater to different clinical applications within general and plastic surgery, such as varying focal depths, energy settings, or transducer designs. The specific differences are detailed in the manufacturer’s technical documentation, which should be consulted to select the appropriate model for a given procedure.
Properties & raw data
Show properties, registry sources and raw records
Sources (2)
- FDA 510(k) K230019
- EUDAMED