Cleared Traditional

K903666 - OPHTHASONIC A/P III (FDA 510(k) Clearance)

Class I Ophthalmic device.

K903666 · Teknar, Inc. · Ophthalmic device
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Nov 1990
Decision
97d
Days
Class 1
Risk

K903666 is an FDA 510(k) clearance for the OPHTHASONIC A/P III. Classified as Unit, Electrolysis, Battery-powered, Ophthalmic (product code HPY), Class I - General Controls.

Submitted by Teknar, Inc. (Fenton, US). The FDA issued a Cleared decision on November 19, 1990 after a review of 97 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4250 - 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 Teknar, Inc. devices

Submission Details

510(k) Number K903666 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 1990
Decision Date November 19, 1990
Days to Decision 97 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 110d · This submission: 97d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HPY Unit, Electrolysis, Battery-powered, Ophthalmic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.4250
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.