SofWave System
K-Number: K250146 · 2025-04-18
ApplicantSofwave Medical, Ltd.
Decision Date2025-04-18
Product CodeNGX
Advisory CommitteePM
DecisionSubstantially Equivalent
Device Summary
SofWave System is a medical device manufactured by Sofwave Medical, Ltd.. It received FDA 510(k) clearance on 2025-04-18 under approval number K250146. The device is classified under product code NGX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the SofWave System?
SofWave System is a medical device that received FDA 510(k) clearance on 2025-04-18. It is manufactured by Sofwave Medical, Ltd.. The 510(k) number is K250146.
When was SofWave System approved by the FDA?
SofWave System received FDA 510(k) clearance on 2025-04-18, under approval number K250146.
What company makes SofWave System?
SofWave System is manufactured by Sofwave Medical, Ltd..
What is the FDA product code for SofWave System?
The FDA product code for SofWave System is NGX.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.