Cleared Traditional

K830011 - VFS 1000/SCREENING FUNCTION ANALYZER

K830011 is an FDA 510(k) clearance for VFS 1000/SCREENING FUNCTION ANALYZER, manufactured by CooperVision, Inc.. The device is a Class 1 Ophthalmic device with product code HOX cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K830011 · CooperVision, Inc. · Ophthalmic device
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Jan 1983
Decision
14d
Days
Class 1
Risk

K830011 is an FDA 510(k) clearance for the VFS 1000/SCREENING FUNCTION ANALYZER. Classified as Chart, Visual Acuity (product code HOX), Class I - General Controls.

Submitted by CooperVision, Inc. (Southampton, GB). The FDA issued a Cleared decision on January 17, 1983 after a review of 14 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 CooperVision, Inc. devices

FDA 510(k) Submission Details - K830011

510(k) Number K830011 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 1983
Decision Date January 17, 1983
Days to Decision 14 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 110d · This submission: 14d
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 8
Devices cleared under the same product code (HOX) and FDA review panel - the closest regulatory comparables to K830011.
MENTOR B-VAT(TM) II VIDEO TESTER
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MENTOR BRIGHTNESS ACUITY TESTER
K853736 · Mentor O & O, Inc. · Nov 1985
NIC OPTRONICS CS-2000
K822215 · Nicolet Biomedical Instruments · Aug 1982
MENTOR POTENTIAL ACUITY METER
K821932 · Mentor O & O, Inc. · Aug 1982
EYE CHARTS
K813376 · Abco Dealers, Inc. · Jan 1982