# Sofwave Medical, Ltd.

- Location (FDA's records): Yokneam Iiit, IL
- FDA decisions: 12 (2019–2025): 12 510(k) clearances
- Product codes: OHV (9), NGX (3)
- 510(k) review time since 2016: median 79 days, against 90 for FDA's reviews in the same codes and years (6 of 8 faster)
- Predicates its devices cite: 16 (10 its own); citations of its devices by later devices: 10 (10 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Ulthera, Inc.: 2 (https://510kreport.com/company/ulthera)
- Soliton, Inc.: 1 (https://510kreport.com/company/soliton)
- Xbody Hungary Kft.: 1 (https://510kreport.com/company/xbody-hungary-kft)
- Johari Digital Healthcare, Ltd.: 1 (https://510kreport.com/company/johari-digital-healthcare)
- Mettler Electronics Corp.: 1 (https://510kreport.com/company/mettler-electronics)

## Its most-cited devices
- K211483: SofWave System (2021), cited by 1
- K223237: SofWave System (2022), cited by 1
- K230019: SofWave System (2023), cited by 1
- K231537: SofWave System (2023), cited by 1
- K250146: SofWave System (2025), cited by 1
- K233104: SofWave System (2023), cited by 1

## Recent decisions
- K251746: Pure Impact (Jul 2, 2025)
- K250146: SofWave System (Apr 18, 2025)
- K241685: SofWave System (Aug 7, 2024)
- K240687: SofWave System (May 30, 2024)
- K233104: SofWave System (Dec 22, 2023)
- K232455: SofWave System (Dec 14, 2023)
- K231537: SofWave System (Aug 28, 2023)
- K230820: SofWave System (Apr 18, 2023)

Source page: https://510kreport.com/company/sofwave-medical