Cleared Traditional

K150826 - Nutra Face Lift Model PE8050 (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K150826 · Nutra Luxe MD, LLC · Neurology device
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Feb 2016
Decision
317d
Days
Class 2
Risk

K150826 is an FDA 510(k) clearance for the Nutra Face Lift Model PE8050. Classified as Stimulator, Transcutaneous Electrical, Aesthetic Purposes (product code NFO), Class II - Special Controls.

Submitted by Nutra Luxe MD, LLC (Fort Myers, US). The FDA issued a Cleared decision on February 10, 2016 after a review of 317 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.

View all Nutra Luxe MD, LLC devices

Submission Details

510(k) Number K150826 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 2015
Decision Date February 10, 2016
Days to Decision 317 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
169d slower than avg
Panel avg: 148d · This submission: 317d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 74
Devices cleared under the same product code (NFO) and FDA review panel - the closest regulatory comparables to K150826.
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