Cleared Traditional

AMO PHACOFLEX INSERTER, FOLDABLE IOL INSERT INSTR

K930320 · Allergan Medical Optics · Ophthalmic
Apr 1994
Decision
440d
Days
Class 1
Risk

About This 510(k) Submission

K930320 is an FDA 510(k) clearance for the AMO PHACOFLEX INSERTER, FOLDABLE IOL INSERT INSTR, a Lens, Guide, Intraocular (Class I — General Controls, product code KYB), submitted by Allergan Medical Optics (Anasco, US). The FDA issued a Cleared decision on April 7, 1994, 440 days after receiving the submission on January 22, 1993. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4300.

Submission Details

510(k) Number K930320 FDA.gov
FDA Decision Cleared SESE
Date Received January 22, 1993
Decision Date April 07, 1994
Days to Decision 440 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement

Device Classification

Product Code KYB — Lens, Guide, Intraocular
Device Class Class I — General Controls
CFR Regulation 21 CFR 886.4300

Similar Devices — KYB Lens, Guide, Intraocular

All 38
MicroSTAAR Injector System Cartridges
K152357 · STAAR Surgical Company · Oct 2015
DUCKWORTH & KENT, LTD., IMPLANTATION SYSTEM, MODEL DK7786
K081382 · Duckworth & Kent, Ltd. · Oct 2008
DUCKWORTH & KENT LTD INJECTOR, MODEL: DK7797-2
K072985 · Duckworth & Kent, Ltd. · Jun 2008
IOL INJECTOR SET
K070669 · Medicel AG · Nov 2007
MONARCH III IOL DELIVERY SYSTEM
K063155 · Alcon Manufacturing, Ltd. · Mar 2007
AKREOS SINGLE USE INSERTION DEVICE, MODEL AI-28
K063694 · Bausch & Lomb, Inc. · Mar 2007