Cleared Traditional

K781313 - VISION-STIMULATOR, CAM (FDA 510(k) Clearance)

Class I Ophthalmic device.

K781313 · Clement Clarke, Inc. · Ophthalmic device
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Jan 1979
Decision
179d
Days
Class 1
Risk

K781313 is an FDA 510(k) clearance for the VISION-STIMULATOR, CAM. Classified as Device, Fixation, Ac-powered, Ophthalmic (product code HPL), Class I - General Controls.

Submitted by Clement Clarke, Inc.. The FDA issued a Cleared decision on January 26, 1979 after a review of 179 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 K781313 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 1978
Decision Date January 26, 1979
Days to Decision 179 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d slower than avg
Panel avg: 110d · This submission: 179d
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.