Sofwave Medical, Ltd.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
12
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K251746Pure ImpactJuly 2, 2025
K250146SofWave SystemApril 18, 2025
K241685SofWave SystemAugust 7, 2024
K240687SofWave SystemMay 30, 2024
K233104SofWave SystemDecember 22, 2023
K232455SofWave SystemDecember 14, 2023
K231537SofWave SystemAugust 28, 2023
K230820SofWave SystemApril 18, 2023
K230019SofWave SystemMarch 14, 2023
K223237SofWave SystemDecember 16, 2022
K211483SofWave SystemNovember 15, 2021
K191421Sofacia SystemSeptember 9, 2019