Cleared Traditional

K122711 - FACIAL SPA

K122711 is an FDA 510(k) clearance for FACIAL SPA, manufactured by Nuskin. The device is a Class 2 Neurology device with product code NFO cleared through the Traditional 510(k) pathway after a 378-day FDA review.

K122711 · Nuskin · Neurology device
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Sep 2013
Decision
378d
Days
Class 2
Risk

K122711 is an FDA 510(k) clearance for the FACIAL SPA. Classified as Stimulator, Transcutaneous Electrical, Aesthetic Purposes (product code NFO), Class II - Special Controls.

Submitted by Nuskin (Washington, US). The FDA issued a Cleared decision on September 17, 2013 after a review of 378 days - an unusually long review period, suggesting complex equivalence evaluation.

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

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FDA 510(k) Submission Details - K122711

510(k) Number K122711 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 2012
Decision Date September 17, 2013
Days to Decision 378 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
230d slower than avg
Panel avg: 148d · This submission: 378d
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.