Cleared Traditional

BYRNE EXPULSIVE LENS (K923670) - FDA 510(k) Clearance

Class I Ophthalmic device.

K923670 · Ocular Instruments, Inc. · Ophthalmic device
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Nov 1992
Decision
117d
Days
Class 1
Risk

K923670 is an FDA 510(k) clearance for the BYRNE EXPULSIVE LENS. Classified as Lens, Fundus, Hruby, Diagnostic (product code HJI), Class I - General Controls.

Submitted by Ocular Instruments, Inc. (Bellevue, US). The FDA issued a Cleared decision on November 16, 1992 after a review of 117 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1395 - 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 Ocular Instruments, Inc. devices

Submission Details

510(k) Number K923670 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 1992
Decision Date November 16, 1992
Days to Decision 117 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
7d slower than avg
Panel avg: 110d · This submission: 117d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HJI Lens, Fundus, Hruby, Diagnostic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.1395
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.