Cleared Traditional

TWO MIRROR GONIO LENS

K895846 · Ocular Instruments, Inc. · Ophthalmic
Dec 1989
Decision
76d
Days
Class 1
Risk

About This 510(k) Submission

K895846 is an FDA 510(k) clearance for the TWO MIRROR GONIO 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 December 18, 1989, 76 days after receiving the submission on October 3, 1989. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1660.

Submission Details

510(k) Number K895846 FDA.gov
FDA Decision Cleared SESE
Date Received October 03, 1989
Decision Date December 18, 1989
Days to Decision 76 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary —

Device Classification

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

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