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
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.

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. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.