Cleared Traditional

KARICKHOFF DIAGNOSTIC/LASER LENS

K862692 · Ocular Instruments, Inc. · Ophthalmic
Aug 1986
Decision
37d
Days
Class 1
Risk

About This 510(k) Submission

K862692 is an FDA 510(k) clearance for the KARICKHOFF DIAGNOSTIC/LASER 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 August 21, 1986, 37 days after receiving the submission on July 15, 1986. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1660.

Submission Details

510(k) Number K862692 FDA.gov
FDA Decision Cleared SESE
Date Received July 15, 1986
Decision Date August 21, 1986
Days to Decision 37 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

Similar Devices — HKS Prism, Gonioscopic

All 9
FAMILY OF DISPOSABLE LENSES
K140368 · Sensor Medical Technology, LLC · Apr 2014
OSHER SURGICAL GONIO/POSTERIOR POLE LENS
K935302 · Ocular Instruments, Inc. · Apr 1994
TWO MIRROR GONIO LENS
K895846 · Ocular Instruments, Inc. · Dec 1989
MCINTYRE SURGICAL GONIOLENS
K890977 · Ocular Instruments, Inc. · May 1989
ABRAHAM IRIDECTOMY LENS (YAG LASER)
K862713 · Ocular Instruments, Inc. · Aug 1986
SUSSMAN FOUR MIRROR HAND HELD GONIOPRISM
K862024 · Ocular Instruments, Inc. · Jul 1986