Cleared Traditional

K171647 - BeneLife Premium Facial Treatment Pack

K171647 is an FDA 510(k) clearance for BeneLife Premium Facial Treatment Pack, manufactured by Infinitus (China) Company , Ltd.. The device is a Class 2 Neurology device with product code NFO cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K171647 · Infinitus (China) Company , Ltd. · Neurology device
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Oct 2017
Decision
140d
Days
Class 2
Risk

K171647 is an FDA 510(k) clearance for the BeneLife Premium Facial Treatment Pack, Model: QZ0701A. Classified as Stimulator, Transcutaneous Electrical, Aesthetic Purposes (product code NFO), Class II - Special Controls.

Submitted by Infinitus (China) Company , Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on October 23, 2017 after a review of 140 days - within the typical 510(k) review window.

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.

View all Infinitus (China) Company , Ltd. devices

FDA 510(k) Submission Details - K171647

510(k) Number K171647 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 2017
Decision Date October 23, 2017
Days to Decision 140 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
8d faster than avg
Panel avg: 148d · This submission: 140d
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 54
Devices cleared under the same product code (NFO) and FDA review panel - the closest regulatory comparables to K171647.
Ultra Facial Toning System
K181062 · Micro Current Technology, Inc. · Jul 2018
TAMA BEMS device
K173093 · Tama Research Corporation · Jun 2018
2 Face / Face Evolution
K171821 · Heat IN A Click · Apr 2018
Everyway Facial MENS
K142794 · Everyway Medical Instruments Co.,Ltd · Jun 2015
BMR FACE
K103031 · Bio-Medical Research, Ltd. · Nov 2011