Cleared Traditional

Cefaly Acute

K171446 · Cefaly Technology · Neurology

Sep 2017

Decision

122d

Days

Class 2

Risk

About This 510(k) Submission

K171446 is an FDA 510(k) clearance for the Cefaly Acute, a Stimulator, Nerve, Electrical, Transcutaneous, For Migraine (Class II — Special Controls, product code PCC), submitted by Cefaly Technology (Seraing, BE). The FDA issued a Cleared decision on September 15, 2017, 122 days after receiving the submission on May 16, 2017. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5891.

Submission Details

510(k) Number	K171446 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 16, 2017
Decision Date	September 15, 2017
Days to Decision	122 days
Submission Type	Traditional
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.