Atlas FDA

IOL INJECTOR SET

FDA 510(k) clearance K070669 · decided 2007-11-01

Clearance details

K-number
K070669
Device name
IOL INJECTOR SET
Applicant
Medicel AG
Decision
Substantially Equivalent
Date received
2007-03-12
Decision date
2007-11-01
Days to decision
234 days
Clearance type
Traditional
Product code
KYB
Device class
1
Regulation number
886.4300
Medical specialty
Ophthalmic
Advisory committee
Ophthalmic
Location
Hasbrouck Heights, NJ, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
MicroSTAAR Injector System Cartridges (K152357)STAAR Surgical Company2015-10-30
DUCKWORTH & KENT, LTD., IMPLANTATION SYSTEM, MODEL DK7786 (K081382)Duckworth & Kent, Ltd.2008-10-23
DUCKWORTH & KENT LTD INJECTOR, MODEL: DK7797-2 (K072985)Duckworth & Kent, Ltd.2008-06-20
MONARCH III IOL DELIVERY SYSTEM (K063155)Alcon Manufacturing, Ltd.2007-03-27
AKREOS SINGLE USE INSERTION DEVICE, MODEL AI-28 (K063694)Bausch & Lomb, Inc.2007-03-07
RE-USEABLE MICROSTAAR INJECTOR, MSI-S (K032412)Staar Surgical Co.2004-06-10
MASTEL 1 FOLDER IMPLANTATION SYSTEM (K022723)Mastel Precision, Inc.2002-12-26
MONARCH II IOL DELIVERY SYSTEM (K001157)Alcon Research, Ltd.2000-06-27
DISPOSABLE MICROSTAAR INJECTOR (MODEL MSI-P1) (K983129)Staar Surgical Co.1998-12-04
MONARCH IOL DELIVERY SYSTEM (K981571)Alcon Laboratories1998-07-09
MONARCH IOL DELIVERY SYSTEM (K970033)Alcon Laboratories1997-04-23
ACRYPAK FOLDER (K965185)Alcon Laboratories1997-03-31

Recalls involving this device

RecordFirmDate
Product Name: nanoPOINT Injector System, item number 37-0000-08. Intended to fold and inse recall (Z-1984-2013)Medicel Ag2013-08-20