Cleared Traditional

IMAGE DEFLECTOR (K833669) - FDA 510(k) Clearance

Class I Ophthalmic device.

K833669 · Michael Onufryk · Ophthalmic device
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Mar 1984
Decision
161d
Days
Class 1
Risk

K833669 is an FDA 510(k) clearance for the IMAGE DEFLECTOR. Classified as Frame, Trial, Ophthalmic (product code HPA), Class I - General Controls.

Submitted by Michael Onufryk (Mchenry, US). The FDA issued a Cleared decision on March 27, 1984 after a review of 161 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1415 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Michael Onufryk devices

Submission Details

510(k) Number K833669 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 1983
Decision Date March 27, 1984
Days to Decision 161 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d slower than avg
Panel avg: 110d · This submission: 161d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HPA Frame, Trial, Ophthalmic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.1415
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.