Not Cleared Direct

DEN240076 - Modius Lean (FDA 510(k) Clearance)

Class I Gastroenterology & Urology device.

DEN240076 · Neurovalens Limited · Gastroenterology & Urology device
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Oct 2025
Decision
303d
Days
Class 1
Risk

DEN240076 is an FDA 510(k) submission (not cleared) for the Modius Lean. Classified as Cranial Electrotherapy Stimulator For Weight Management (product code SFW), Class I - General Controls.

Submitted by Neurovalens Limited (Portglenone, GB). The FDA issued a Not Cleared (DENG) decision on October 17, 2025 after a review of 303 days.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5984 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 303 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Neurovalens Limited devices

Submission Details

510(k) Number DEN240076 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received December 18, 2024
Decision Date October 17, 2025
Days to Decision 303 days
Submission Type Direct
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
173d slower than avg
Panel avg: 130d · This submission: 303d
Pathway characteristics

Device Classification

Product Code SFW Cranial Electrotherapy Stimulator For Weight Management
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 876.5984
Definition A Cranial Electrotherapy Stimulator For Weight Management Is A Battery-powered Device That Applies Electrical Current To A Patient's Head Through Electrodes Placed On The Skin To Support Weight Management In Conjunction With Diet And Exercise. Devices In This Classification Use A Low Level Of Electrical Current That Is Not Intended To Induce A Seizure.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.