BETA
Ultrasound and electrical-muscle-stimulation platforms for non-invasive aesthetic treatment.
Sofwave Medical develops energy-based aesthetic devices for clinician practices. Its SUPERB ultrasound technology delivers controlled energy to dermal tissue for labeled skin treatments, while the Pure Impact platform uses electrical muscle stimulation for strengthening, toning and firming.
The portfolio separates ultrasound-based skin applications from EMS-based muscle treatment. FDA decisions for the SofWave System and Pure Impact are documented individually; a device’s clearance does not extend automatically to every promotional claim, body area or future accessory.
Louis Scafuri is CEO and Assaf Korner is CFO. The Israel-based company has U.S. operations in San Clemente and trades on the Tel Aviv Stock Exchange as SOFW. In August 2026 it reported surpassing one million treatments worldwide, a company-reported utilization milestone rather than a count of unique patients.
Sofwave’s ultrasound platform and Pure Impact electrical-muscle-stimulation products have multiple 510(k) decisions. Device records link the earlier Sofacia name to Sofwave, and link K232455 and K241685 to Pure Impact hardware. These distinct technologies and indication updates are now separated rather than attributing every clearance to the ultrasound device. [26][30][31][11][8][22][24][1]
No matching FDA recall event was identified in the completed company/applicant, linked-identifier and product-name searches. [17][15]
Latest recorded source review: 2026-10-20.
Documented commercial product families.
Non-invasive ultrasound-based aesthetic treatment with product-specific indications. [26][30]
FDA-clearedCommercially offered; exact model and country availability should be confirmed with the manufacturer.
EMS module and standalone platform; platform-specific indications and configuration apply. [26][31]
FDA-clearedCommercially offered; exact model and country availability should be confirmed with the manufacturer.
Company reported cumulative worldwide treatments; not unique patients or independently audited outcomes. [28]
FDA K251746 decision is July 2, 2025; public launch announcement followed in September. [31]
Accessed 10/29/2026