SofWave System
by Sofwave Medical Ltd Israel EUDAMED510(k)
510(k) K250146
Product code NGX
Overview
The SofWave System is a non-invasive ultrasound device classified under the Physical Medicine category, designed for dermatological aesthetic treatments. It employs focused ultrasound energy to target deeper skin layers, promoting tissue remodeling and collagen stimulation to address facial lines, wrinkles, and short-term cellulite appearance improvements. Its mechanism relies on controlled ultrasound waves to enhance skin elasticity and texture without surgical intervention.
The device is supplied as a reusable medical system intended for clinical use in aesthetic medicine settings. It is not described as sterile for single-use but requires proper maintenance and calibration as per manufacturer guidelines. The system’s regulatory status includes FDA 510(k) clearance under the Physical Medicine advisory committee and compliance with the MDD (Medical Device Directive). No specific MRI safety classification or size variations are noted in the available data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK250146 | Date18 Apr 2025 | 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
- NGX
- FDA applicant
- Sofwave Medical, Ltd.
- Device Class
- Class II
- Regulation
- 21 CFR Part 890.5850
- Advisory Committee
- Physical Medicine
- FDA Decision
- SESE Substantially Equivalent
Other devices from Sofwave Medical Ltd
Questions
What types of skin concerns can the SofWave System address, and how does it work to improve them?
The SofWave System is designed for non-invasive dermatological treatments targeting facial lines, wrinkles, and short-term cellulite appearance. It uses focused ultrasound energy to stimulate deeper skin layers, promoting tissue remodeling and collagen production. This process enhances skin elasticity and texture, helping to reduce the visible signs of aging and improve skin firmness without surgery.
Is the SofWave System intended for single-use or reusable clinical settings, and what maintenance is required?
The SofWave System is supplied as a reusable medical device meant for clinical use in aesthetic medicine settings. Since it is not described as sterile for single-use, proper maintenance and calibration are essential as outlined by the manufacturer. Regular upkeep ensures consistent performance and safety in dermatological treatments.
How is the regulatory approval for the SofWave System structured, and which advisory committee was involved?
The SofWave System holds FDA 510(k) clearance under the Physical Medicine category, classified as substantially equivalent. The device was reviewed by the Physical Medicine (PM) advisory committee, with the submission filed under product code NGX. It also complies with the Medical Device Directive (MDD).
Are there different sizes or models available for the SofWave System, or is it a single-device configuration?
The available data does not specify any size variations or multiple models for the SofWave System. It is described as a single, reusable medical system designed for focused ultrasound treatments in dermatology, without mention of customizable settings or configurations.
Properties & raw data
Show properties, registry sources and raw records
Sources (2)
- FDA 510(k) K250146
- EUDAMED