Cleared Traditional

Cefaly Dual

K201895 · Cefaly Technology · Neurology

Sep 2020

Decision

83d

Days

Class 2

Risk

About This 510(k) Submission

K201895 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 September 29, 2020, 83 days after receiving the submission on July 8, 2020. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5891.

Submission Details

510(k) Number	K201895 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 08, 2020
Decision Date	September 29, 2020
Days to Decision	83 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.