Cleared Traditional

MICROSTAAR INJECTOR MODELS MSI-TD & MSI-PD (MODIFICATION)

K954600 · Staar Surgical Co. · Ophthalmic
Dec 1995
Decision
87d
Days
Class 1
Risk

About This 510(k) Submission

K954600 is an FDA 510(k) clearance for the MICROSTAAR INJECTOR MODELS MSI-TD & MSI-PD (MODIFICATION), a Lens, Guide, Intraocular (Class I — General Controls, product code KYB), submitted by Staar Surgical Co. (Monrovia, US). The FDA issued a Cleared decision on December 21, 1995, 87 days after receiving the submission on September 25, 1995. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4300.

Submission Details

510(k) Number K954600 FDA.gov
FDA Decision Cleared SESE
Date Received September 25, 1995
Decision Date December 21, 1995
Days to Decision 87 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

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