Cleared Traditional

BYRNE EXPULSIVE LENS

K923670 · Ocular Instruments, Inc. · Ophthalmic
Nov 1992
Decision
117d
Days
Class 1
Risk

About This 510(k) Submission

K923670 is an FDA 510(k) clearance for the BYRNE EXPULSIVE LENS, a Lens, Fundus, Hruby, Diagnostic (Class I — General Controls, product code HJI), submitted by Ocular Instruments, Inc. (Bellevue, US). The FDA issued a Cleared decision on November 16, 1992, 117 days after receiving the submission on July 22, 1992. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1395.

Submission Details

510(k) Number K923670 FDA.gov
FDA Decision Cleared SESE
Date Received July 22, 1992
Decision Date November 16, 1992
Days to Decision 117 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement

Device Classification

Product Code HJI — Lens, Fundus, Hruby, Diagnostic
Device Class Class I — General Controls
CFR Regulation 21 CFR 886.1395

Similar Devices — HJI Lens, Fundus, Hruby, Diagnostic

All 7
60 FUNDUS CAMERA CF-60UV
K901839 · Canon USA, Inc. · Jul 1990
STRIPE PROJECTOR
K902138 · Academic Catalyst Corp. · Jul 1990
LASER IMAGING WORK STATION
K897186 · Innovision Medical, Inc. · Mar 1990
OMS QUARTZ INFUSION CONTACT LENS
K820223 · Optical Micro Systems, Inc. · Feb 1982
SEBESTYEN IRRIGATING CONTACT LENS
K802927 · Cooper Medical Devices Corp. · Feb 1981
LANDERS CONTACT LENS
K802971 · Cooper Medical Devices Corp. · Feb 1981