Cleared Traditional

K152112 - VisualEyes

K152112 is the FDA 510(k) clearance for VisualEyes by Interacoustics A/S. It is a Class 2 Neurology device (product code GWN) cleared through the Traditional 510(k) pathway after a 153-day FDA review.

K152112 · Interacoustics A/S · Neurology device
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Dec 2015
Decision
153d
Days
Class 2
Risk

K152112 is an FDA 510(k) clearance for the VisualEyes. Classified as Nystagmograph (product code GWN), Class II - Special Controls.

Submitted by Interacoustics A/S (Middelfart, DK). The FDA issued a Cleared decision on December 29, 2015 after a review of 153 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1460 - 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 Interacoustics A/S devices

Submission Details

510(k) Number K152112 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 2015
Decision Date December 29, 2015
Days to Decision 153 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
5d slower than avg
Panel avg: 148d · This submission: 153d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GWN Nystagmograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1460
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 - GWN Nystagmograph

All 13
Devices cleared under the same product code (GWN) and FDA review panel - the closest regulatory comparables to K152112.
RightEye Vision System
K181771 · Righteye, LLC · Sep 2018
DizzyDoctor System 1.0.0
K182214 · Dizzydoctor Systems, LLC · Sep 2018
I-Portal Neuro Otologic Test Center
K181025 · Neuro Kinetics, Inc. · Jul 2018
JANUS ATAC ENG ANALYSIS SYSTEM
K904385 · Life-Tech Intl., Inc. · Jun 1992
NAGASHIMA NS-III ELECTRONYSTAGMOGRAPH
K822268 · Kelleher Corp. · Jan 1983
NAGASHIMA KN-52 SACCADE & PURSUIT STIM
K822266 · Kelleher Corp. · Aug 1982