Cleared Traditional

OSHER SURGICAL GONIO/POSTERIOR POLE LENS

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

About This 510(k) Submission

K935302 is an FDA 510(k) clearance for the OSHER SURGICAL GONIO/POSTERIOR POLE LENS, a Prism, Gonioscopic (Class I — General Controls, product code HKS), submitted by Ocular Instruments, Inc. (Bellevue, US). The FDA issued a Cleared decision on April 1, 1994, 150 days after receiving the submission on November 2, 1993. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1660.

Submission Details

510(k) Number K935302 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code HKS — Prism, Gonioscopic
Device Class Class I — General Controls
CFR Regulation 21 CFR 886.1660

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