Cleared Traditional

Cefaly Dual

K173006 · Cefaly Technology · Neurology

Nov 2017

Decision

62d

Days

Class 2

Risk

About This 510(k) Submission

K173006 is an FDA 510(k) clearance for the Cefaly Dual, 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 November 28, 2017, 62 days after receiving the submission on September 27, 2017. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5891.

Submission Details

510(k) Number	K173006 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 27, 2017
Decision Date	November 28, 2017
Days to Decision	62 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.