Cefaly Technology FDA Approvals

0 new drug approvals and 2 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
CEFALY Connected - OTC, CEFALY Connected - Rx510(k)Jul 18, 2024Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Jul 18, 2024
Cefaly Dual Enhanced with RFID - OTC, Cefaly Dual Enhanced with RFID - Rx, Cefaly Dual Connected - OTC, Cefaly Dual Connected - Rx510(k)Dec 13, 2022Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Dec 13, 2022