Cleared Traditional

K122784 - NESS L300 SYSTEM KIT, LEF MODEL LG3-5100

Also marketed or referenced as:
NESS L300 SYSTEM KIT, RIGHT MODEL LG3-5000 SMALL NESS L300 SYSTEM KIT, RIGHT

K122784 is an FDA 510(k) clearance for NESS L300 SYSTEM KIT, manufactured by Bioness, Inc.. The device is a Class 2 Neurology device with product code GZI cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K122784 · Bioness, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2012
Decision
107d
Days
Class 2
Risk

K122784 is an FDA 510(k) clearance for the NESS L300 SYSTEM KIT, LEF MODEL LG3-5100. Classified as Stimulator, Neuromuscular, External Functional (product code GZI), Class II - Special Controls.

Submitted by Bioness, Inc. (Valencia, US). The FDA issued a Cleared decision on December 27, 2012 after a review of 107 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5810 - 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 Bioness, Inc. devices

FDA 510(k) Submission Details - K122784

510(k) Number K122784 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 2012
Decision Date December 27, 2012
Days to Decision 107 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
42d faster than avg
Panel avg: 149d · This submission: 107d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GZI Device Classification - Class 2, Special Controls

Product Code GZI Stimulator, Neuromuscular, External Functional
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5810
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 - GZI Stimulator, Neuromuscular, External Functional

All 55
Devices cleared under the same product code (GZI) and FDA review panel - the closest regulatory comparables to K122784.
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