Cleared Traditional

K261625 - FAQ™ (FAQ 401)

Also marketed or referenced as:
FAQ™ (FAQ 402)

K261625 is an FDA 510(k) clearance for FAQ (FAQ 401), manufactured by Foreo, Inc.. The device is a Class 2 Neurology device with product code NFO cleared through the Traditional 510(k) pathway after a 164-day FDA review.

K261625 · Foreo, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
164d
Days
Class 2
Risk

K261625 is an FDA 510(k) clearance for the FAQ™ (FAQ 401). Classified as Stimulator, Transcutaneous Electrical, Aesthetic Purposes (product code NFO), Class II - Special Controls.

Submitted by Foreo, Inc. (Las Vegas, US). The FDA issued a Cleared decision on October 26, 2026 after a review of 164 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5890 - 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.

FDA 510(k) Submission Details - K261625

510(k) Number K261625 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 2026
Decision Date October 26, 2026
Days to Decision 164 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
15d slower than avg
Panel avg: 149d · This submission: 164d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NFO Device Classification - Class 2, Special Controls

Product Code NFO Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5890
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 Consultant

DD Consulting
Domljanovic Danijela

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - NFO Stimulator, Transcutaneous Electrical, Aesthetic Purposes

All 82
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K261625 · FAQ™ (FAQ 401)
Download PDF FDA Summary Foreo, Inc.