Cleared Traditional

K853481 - VISTECH VCTS GLARE TESTER

K853481 is an FDA 510(k) clearance for VISTECH VCTS GLARE TESTER, manufactured by Vistech Consultants, Inc.. The device is a Class 1 Ophthalmic device with product code HOX cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K853481 · Vistech Consultants, Inc. · Ophthalmic device
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Oct 1985
Decision
70d
Days
Class 1
Risk

K853481 is an FDA 510(k) clearance for the VISTECH VCTS GLARE TESTER. Classified as Chart, Visual Acuity (product code HOX), Class I - General Controls.

Submitted by Vistech Consultants, Inc. (Dayton, US). The FDA issued a Cleared decision on October 29, 1985 after a review of 70 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1150 - the FDA ophthalmic 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Vistech Consultants, Inc. devices

FDA 510(k) Submission Details - K853481

510(k) Number K853481 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 1985
Decision Date October 29, 1985
Days to Decision 70 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 110d · This submission: 70d
Pathway characteristics
Predicate-based equivalence.

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 9
Devices cleared under the same product code (HOX) and FDA review panel - the closest regulatory comparables to K853481.
MENTOR B-VAT(TM) II VIDEO TESTER
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CANON AUTO ACUITOMETER CV-10
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MENTOR BRIGHTNESS ACUITY TESTER
K853736 · Mentor O & O, Inc. · Nov 1985
VFS 1000/SCREENING FUNCTION ANALYZER
K830011 · CooperVision, Inc. · Jan 1983
NIC OPTRONICS CS-2000
K822215 · Nicolet Biomedical Instruments · Aug 1982
MENTOR POTENTIAL ACUITY METER
K821932 · Mentor O & O, Inc. · Aug 1982