Cleared Traditional

K152112 - VisualEyes

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

K152112 · Interacoustics A/S · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K152112

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 149d · This submission: 153d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GWN Device Classification - Class 2, Special Controls

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 55
Devices cleared under the same product code (GWN) and FDA review panel - the closest regulatory comparables to K152112.
Synapsys Ulmer Video Nystagmograph
K163558 · Synapsys SA · Mar 2017
ISEN-Goggles
K152727 · Isen Tech & Trading Company, Ltd. · Apr 2016
EYE-SYNC
K152915 · Syncthink, Inc. · Jan 2016
ICS Impulse
K151504 · Gn Otometrics · Nov 2015
I-Portal NOTC, VNG and VOG
K143607 · Neuro Kinetics, Inc. · Jul 2015
EYESEECAM VHIT
K131681 · Interacoustics A/S · Sep 2013
K152112 · VisualEyes
Download PDF FDA Summary Interacoustics A/S