Cleared Abbreviated

K100095 - CENTRAL VISION ANALYZER MODEL 1000

K100095 is an FDA 510(k) clearance for CENTRAL VISION ANALYZER MODEL 1000, manufactured by Vimetrics,Llc.. The device is a Class 1 Ophthalmic device with product code HOX cleared through the Abbreviated 510(k) pathway after a 117-day FDA review.

K100095 · Vimetrics,Llc. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2010
Decision
117d
Days
Class 1
Risk

K100095 is an FDA 510(k) clearance for the CENTRAL VISION ANALYZER MODEL 1000. Classified as Chart, Visual Acuity (product code HOX), Class I - General Controls.

Submitted by Vimetrics,Llc. (Media, US). The FDA issued a Cleared decision on May 10, 2010 after a review of 117 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1150 - the FDA ophthalmic device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K100095

510(k) Number K100095 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 2010
Decision Date May 10, 2010
Days to Decision 117 days
Submission Type Abbreviated
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
7d slower than avg
Panel avg: 110d · This submission: 117d
Pathway characteristics
Standards-based clearance path.

HOX Device Classification - Class 1, General Controls

Product Code HOX Chart, Visual Acuity
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.1150
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 - HOX Chart, Visual Acuity

All 28
Devices cleared under the same product code (HOX) and FDA review panel - the closest regulatory comparables to K100095.
HEINE LAMBDA 100
K944156 · Heine USA , Ltd. · Jan 1995
OCCU-TECH VISION TEST
K881971 · Applied Vision Concepts, Inc. · Nov 1988
PL 20/20 INFANT VISION TESTER
K883337 · Optimed Technologies, Inc. · Oct 1988
VISUAL CONTRAST SENSITI., POTENTIAL ACUITY&GLARE
K882634 · Vistech Consultants, Inc. · Jul 1988
PG CONSEN CONTRAST SENSITIVITY TESTING PROGRAM
K881358 · Neuroscientific Corp. · Jun 1988
MCT 8000 (MULTI-VISION CONTRAST TESTER)
K881059 · Vistech Consultants, Inc. · Apr 1988
K100095 · CENTRAL VISION ANALYZER MODEL 1000
Download PDF FDA Summary Vimetrics,Llc.