Cleared Traditional

K120511 - AGELESS WONDER FACIAL MUSCLE STIMULATION SYSTEM

K120511 is an FDA 510(k) clearance for AGELESS WONDER FACIAL MUSCLE STIMULATIO..., manufactured by Leto Enterprise , Ltd.. The device is a Class 2 Neurology device with product code NFO cleared through the Traditional 510(k) pathway after a 160-day FDA review.

K120511 · Leto Enterprise , Ltd. · Neurology device
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Jul 2012
Decision
160d
Days
Class 2
Risk

K120511 is an FDA 510(k) clearance for the AGELESS WONDER FACIAL MUSCLE STIMULATION SYSTEM. Classified as Stimulator, Transcutaneous Electrical, Aesthetic Purposes (product code NFO), Class II - Special Controls.

Submitted by Leto Enterprise , Ltd. (Wanchai, HK). The FDA issued a Cleared decision on July 30, 2012 after a review of 160 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.

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FDA 510(k) Submission Details - K120511

510(k) Number K120511 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 2012
Decision Date July 30, 2012
Days to Decision 160 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
12d slower than avg
Panel avg: 148d · This submission: 160d
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.