Cleared Traditional

K023623 - NOVAVISION, MODEL 2.0

K023623 is an FDA 510(k) clearance for NOVAVISION, manufactured by Novavision, Inc.. The device is a Class 1 Neurology device with product code HPT cleared through the Traditional 510(k) pathway after a 175-day FDA review.

K023623 · Novavision, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2003
Decision
175d
Days
Class 1
Risk

K023623 is an FDA 510(k) clearance for the NOVAVISION, MODEL 2.0. Classified as Perimeter, Automatic, Ac-powered (product code HPT), Class I - General Controls.

Submitted by Novavision, Inc. (Washington, US). The FDA issued a Cleared decision on April 22, 2003 after a review of 175 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 886.1605 - 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 Novavision, Inc. devices

FDA 510(k) Submission Details - K023623

510(k) Number K023623 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 2002
Decision Date April 22, 2003
Days to Decision 175 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
27d slower than avg
Panel avg: 148d · This submission: 175d
Pathway characteristics
Predicate-based equivalence.

HPT Device Classification - Class 1, General Controls

Product Code HPT Perimeter, Automatic, Ac-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.1605
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.

Regulatory Peers - HPT Perimeter, Automatic, Ac-powered

All 10
Devices cleared under the same product code (HPT) and FDA review panel - the closest regulatory comparables to K023623.
GUIDED PROGRESSION ANALYSIS ON THE HUMPHREY FIELD ANALYZER II AND II -I SERIES
K093213 · Carl Zeiss Meditec, Inc. · Mar 2010
KASHA VISUAL FIELD SYSTEM
K971156 · Kasha Software, Inc. · May 1997
AUTOMATIC VISUAL FIELD PLOTTER AP-125
K961090 · Kowa Optimed, Inc. · Jun 1996
HUMPHREY FIELD ANALYZER (HFA II)
K954167 · Carl Zeiss, Inc. · Nov 1995
DIGILAB MODEL 1500 PERIMETER
K870120 · Bio-Rad · Feb 1987
DIGILAB 750 AUTOMATED PERIMETER W/IBM PERSON/COMPU
K850191 · Bio-Rad · Mar 1985