Cleared Traditional

Cefaly Dual (K201895) - FDA 510(k) Clearance

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

K201895 · Cefaly Technology · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2020
Decision
83d
Days
Class 2
Risk

K201895 is an FDA 510(k) clearance for the Cefaly Dual. 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 29, 2020 after a review of 83 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Cefaly Technology devices

Submission Details

510(k) Number K201895 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 148d · This submission: 83d
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 13
Devices cleared under the same product code (PCC) and FDA review panel - the closest regulatory comparables to K201895.
Elexir
K211380 · Nu Eyne Co., Ltd. · Jul 2021
Migraine Tens Digital Pain Reliever
K210364 · Shenzhen Dongdixin Technology Co., Ltd. · Jun 2021
Relivion
K203419 · Neurolief , Ltd. · Feb 2021
ALLIVE
K192773 · Nu Eyne Co., Ltd. · Dec 2019
TENS device-HeadaTerm, eEspress
K172450 · Wat Medical Technology (Ningbo) Co., Ltd. · Sep 2018