Cleared Traditional

K935302 - OSHER SURGICAL GONIO/POSTERIOR POLE LENS

K935302 is an FDA 510(k) clearance for OSHER SURGICAL GONIO/POSTERIOR POLE LENS, manufactured by Ocular Instruments, Inc.. The device is a Class 1 Ophthalmic device with product code HKS cleared through the Traditional 510(k) pathway after a 150-day FDA review.

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

FDA 510(k) Submission Details - K935302

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
40d slower than avg
Panel avg: 110d · This submission: 150d
Pathway characteristics
Predicate-based equivalence.

HKS Device Classification - Class 1, General Controls

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.

Regulatory Peers - HKS Prism, Gonioscopic

All 8
Devices cleared under the same product code (HKS) and FDA review panel - the closest regulatory comparables to K935302.
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