Cleared Traditional

360 DEGREE FIXATION LIGHT (K933739) - FDA 510(k) Clearance

Class I Ophthalmic device.

K933739 · Varitronics · Ophthalmic device
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Mar 1994
Decision
223d
Days
Class 1
Risk

K933739 is an FDA 510(k) clearance for the 360 DEGREE FIXATION LIGHT. Classified as Device, Fixation, Ac-powered, Ophthalmic (product code HPL), Class I - General Controls.

Submitted by Varitronics (Broomall, US). The FDA issued a Cleared decision on March 14, 1994 after a review of 223 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1290 - 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.

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Submission Details

510(k) Number K933739 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 1993
Decision Date March 14, 1994
Days to Decision 223 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
113d slower than avg
Panel avg: 110d · This submission: 223d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HPL Device, Fixation, Ac-powered, Ophthalmic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.1290
Definition A Fixation Device Is An Ac-powered Device Intended For Use As A Fixation Target For The Patient During Ophthalmologic Examination. The Patient Directs His Or Her Gaze So That The Visual Image Of The Object Falls On The Fovea Centralis (the Center Of The Macular Retina Of The Eye.)
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.