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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
11d slower than avg
Panel avg: 149d · 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.

Regulatory Peers - NFO Stimulator, Transcutaneous Electrical, Aesthetic Purposes

All 80
Devices cleared under the same product code (NFO) and FDA review panel - the closest regulatory comparables to K120511.
NUFACE MINI DEVICE
K133823 · Carol Cole Company · Apr 2014
TRINITY ELE
K131251 · Carol Cole Company · Oct 2013
FACIAL SPA
K122711 · Nuskin · Sep 2013
ULTRA BEAUTY
K112351 · Johari Digital Healthcare , Ltd. · Mar 2012
ELECTROPULSE-COSMETIC
K113724 · Pain Relief Technologies · Feb 2012
THE BUZZ FACIAL TONING SYSTEM
K102494 · Daka International , Ltd. · Dec 2011
K120511 · AGELESS WONDER FACIAL MUSCLE STIMULATION SYSTEM
Download PDF FDA Summary Leto Enterprise , Ltd.