Cleared Traditional

K935302 - OSHER SURGICAL GONIO/POSTERIOR POLE LENS

K935302 is the FDA 510(k) clearance for OSHER SURGICAL GONIO/POSTERIOR POLE LENS by Ocular Instruments, Inc.. It is a Class 1 Ophthalmic device (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

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
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.

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.

Regulatory Peers - HKS Prism, Gonioscopic

All 7
Devices cleared under the same product code (HKS) and FDA review panel - the closest regulatory comparables to K935302.
TWO MIRROR GONIO LENS
K895846 · Ocular Instruments, Inc. · Dec 1989
MCINTYRE SURGICAL GONIOLENS
K890977 · Ocular Instruments, Inc. · May 1989
KARICKHOFF DIAGNOSTIC/LASER LENS
K862692 · Ocular Instruments, Inc. · Aug 1986
ABRAHAM IRIDECTOMY LENS (YAG LASER)
K862713 · Ocular Instruments, Inc. · Aug 1986
SUSSMAN FOUR MIRROR HAND HELD GONIOPRISM
K862024 · Ocular Instruments, Inc. · Jul 1986
RITCH TRABECULOPLASTY LASER LENS
K862512 · Ocular Instruments, Inc. · Jul 1986