Sofwave Medical, Ltd. FDA Approvals

0 new drug approvals and 11 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
Pure Impact510(k)Jul 2, 2025Physical Medicine	Physical Medicine	510(k)Substantially Equivalent (Special)	Jul 2, 2025
SofWave System510(k)Apr 18, 2025Physical Medicine	Physical Medicine	510(k)Substantially Equivalent (Traditional)	Apr 18, 2025
SofWave System510(k)Aug 7, 2024Physical Medicine	Physical Medicine	510(k)Substantially Equivalent (Traditional)	Aug 7, 2024
SofWave System510(k)May 30, 2024General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	May 30, 2024
SofWave System510(k)Dec 22, 2023General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	Dec 22, 2023
SofWave System510(k)Dec 14, 2023General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	Dec 14, 2023
SofWave System510(k)Aug 28, 2023General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	Aug 28, 2023
SofWave System510(k)Apr 18, 2023General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Special)	Apr 18, 2023
SofWave System510(k)Mar 14, 2023General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	Mar 14, 2023
SofWave System510(k)Dec 16, 2022General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	Dec 16, 2022
SofWave System510(k)Nov 15, 2021General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	Nov 15, 2021