Cleared Traditional

K171446 - Cefaly Acute

K171446 is an FDA 510(k) clearance for Cefaly Acute, manufactured by Cefaly Technology. The device is a Class 2 Neurology device with product code PCC cleared through the Traditional 510(k) pathway after a 122-day FDA review.

K171446 · Cefaly Technology · Neurology device
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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

FDA 510(k) Submission Details - K171446

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 149d · This submission: 122d
Pathway characteristics
Predicate-based equivalence.

PCC Device Classification - Class 2, Special Controls

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Neurology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT02616978 Completed Observational Industry-sponsored

Retrospective Study on the Use of CEFALY® Device During Migraine Attacks

807
Patients (actual)
Condition studied Migraine
Eligibility All sexes
Sponsor Cefaly Technology (industry)
Started 2015-11-01 → Primary completion 2015-12-01
Primary outcome
Monthly number of acute drug intake avoided when using Cefaly to treat a migraine attack
Secondary outcome
Proportion of Cefaly users that report using also the device to treat migraine attacks
Study completed - no results published. This trial concluded in 2015 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov

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.
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