Cleared Traditional

DIOPSYS NOVA VEP VISION TESTING SYSTEM (K101763) - FDA 510(k) Clearance

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

K101763 · Diopsys, Inc. · Neurology device
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May 2011
Decision
320d
Days
Class 2
Risk

K101763 is an FDA 510(k) clearance for the DIOPSYS NOVA VEP VISION TESTING SYSTEM. Classified as Stimulator, Photic, Evoked Response (product code GWE), Class II - Special Controls.

Submitted by Diopsys, Inc. (Pine Brook, US). The FDA issued a Cleared decision on May 9, 2011 after a review of 320 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1890 - 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 Diopsys, Inc. devices

Submission Details

510(k) Number K101763 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 2010
Decision Date May 09, 2011
Days to Decision 320 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
172d slower than avg
Panel avg: 148d · This submission: 320d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GWE Stimulator, Photic, Evoked Response
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1890
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 - GWE Stimulator, Photic, Evoked Response

All 48
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