Cleared Traditional

K171446 - Cefaly Acute (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K171446 · Cefaly Technology · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2017
Decision
122d
Days
Class 2
Risk

K171446 is an FDA 510(k) clearance for the Cefaly Acute. Classified as Stimulator, Nerve, Electrical, Transcutaneous, For Migraine (product code PCC), Class II - Special Controls.

Submitted by Cefaly Technology (Seraing, BE). The FDA issued a Cleared decision on September 15, 2017 after a review of 122 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5891 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Cefaly Technology devices

Submission Details

510(k) Number K171446 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 148d · This submission: 122d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PCC Stimulator, Nerve, Electrical, Transcutaneous, For Migraine
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - PCC Stimulator, Nerve, Electrical, Transcutaneous, For Migraine

All 17
Devices cleared under the same product code (PCC) and FDA review panel - the closest regulatory comparables to K171446.
Enso for Migraine
K254216 · Hinge Health, Inc. · Apr 2026
ELEXIR 2.0 (ALLIVE3)
K242719 · Nu Eyne Co., Ltd. · Nov 2024
CEFALY Connected - OTC, CEFALY Connected - Rx
K234029 · Cefaly Technology · Jul 2024
DOOPANG
K232749 · Ybrain, Inc. · Jun 2024
Milieve (YPS-301BD)
K233751 · Soterix Medical, Inc. · Jun 2024
TENS device-HeadaTerm 2 (Model: YF-HT2)
K230782 · Wat Medical Technology, Inc. · Feb 2024