Cleared Traditional

OSHER SURGICAL GONIO/POSTERIOR POLE LENS (K935302) - FDA 510(k) Clearance

Class I Ophthalmic device.

K935302 · Ocular Instruments, Inc. · Ophthalmic device
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Apr 1994
Decision
150d
Days
Class 1
Risk

K935302 is an FDA 510(k) clearance for the OSHER SURGICAL GONIO/POSTERIOR POLE LENS. Classified as Prism, Gonioscopic (product code HKS), Class I - General Controls.

Submitted by Ocular Instruments, Inc. (Bellevue, US). The FDA issued a Cleared decision on April 1, 1994 after a review of 150 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1660 - 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 K935302 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 1993
Decision Date April 01, 1994
Days to Decision 150 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
40d slower than avg
Panel avg: 110d · This submission: 150d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HKS Prism, Gonioscopic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.1660
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.