Cleared Special

Cefaly

K160237 · Cefaly Technology · Neurology

Mar 2016

Decision

32d

Days

Class 2

Risk

About This 510(k) Submission

K160237 is an FDA 510(k) clearance for the Cefaly, a Stimulator, Nerve, Electrical, Transcutaneous, For Migraine (Class II — Special Controls, product code PCC), submitted by Cefaly Technology (Herstal, BE). The FDA issued a Cleared decision on March 4, 2016, 32 days after receiving the submission on February 1, 2016. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5891.

Submission Details

510(k) Number	K160237 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 01, 2016
Decision Date	March 04, 2016
Days to Decision	32 days
Submission Type	Special
Review Panel	Neurology (NE)
Summary	Summary PDF

Device Classification

Product Code	PCC — Stimulator, Nerve, Electrical, Transcutaneous, For Migraine
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 882.5891
Definition	Used To Apply An Electrical Current To A Patient's Cranium Through Electrodes Placed On The Skin.