FDA 510(k)
Premarket Notification Clearance
Medical Device Clearance
The FDA 510(k) clearance is a specific premarket submission made to the FDA to demonstrate that our device is safe and effective—substantially equivalent to a legally marketed device that is not subject to premarket approval.
Verified device safety and efficacy
Substantial equivalence to legally marketed devices
FDA 510(k) Clearance
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Proven Performance
Our FDA 510(k) clearance is the result of extensive testing and validation. It confirms that our technology not only meets but exceeds the necessary requirements for safety and effectiveness, providing healthcare professionals and consumers with confidence in using our devices.