Folders And Injectors, Intraocular Lens (Iol)

FDA product code MSS · 55 cleared devices

Class 1 Ophthalmic

Regulation: 21 CFR 886.4300
Review panel: OP
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1997-12-17 – 2026-06-10

MSS 2026-06-10

RxSight® Insertion Device

Applicant Rxsight, Inc.

K number K261174

View details →

MSS 2025-09-16

ACCUJECT Injector Set 2.1-1P (LP604590)

Applicant Medicel AG

K number K252540

View details →

MSS 2024-10-10

EyeGility™ Inserter for Preloaded enVista IOLs

Applicant Bausch & Lomb, Incorporated

K number K242389

View details →

MSS 2023-09-19

Accuject Refra Injector AR2900

Applicant Medicel AG

K number K231106

View details →

MSS 2023-08-15

RxSight® Insertion Device (63002)

Applicant Rxsight, Inc.

K number K231838

View details →

MSS 2023-06-12

RxSight Insertion Device

Applicant Rxsight, Inc.

K number K231466

View details →

MSS 2021-08-23

CLAREON MONARCH IV IOL Delivery System

Applicant Alcon Laboratories, Inc.

K number K212039

View details →

MSS 2020-06-04

bioli lOL Delivery System

Applicant Ast Products, Inc.

K number K200057

View details →

MSS 2020-01-17

RxSight Insertion Device

Applicant Rxsight, Inc.

K number K192926

View details →

MSS 2019-10-04

Bausch + Lomb PreVue Inserter for enVista Preloaded

Applicant Bausch & Lomb, Inc.

K number K192005

View details →

MSS 2019-09-13

UNFOLDER Vitan Inserter

Applicant Johnson & Johnson Surgical Vision, Inc.

K number K191949

View details →

MSS 2019-03-29

BL-Cart IOL Delivery Cartridge

Applicant Ast Products, Inc.

K number K182965

View details →

MSS 2018-07-26

RxSight Insertion Device

Applicant Rxsight, Inc.

K number K181401

View details →

MSS 2017-12-15

pioli IOL Delivery System

Applicant Ast Products, Inc.

K number K172228

View details →

MSS 2017-12-11

Crystalsert Lens Delivery System

Applicant Bausch & Lomb, Inc.

K number K173480

View details →

MSS 2017-09-06

MicroSTAAR Injector System Cartridges

Applicant STAAR Surgical Company

K number K172375

View details →

MSS 2016-11-29

Lenstec LC Injection system

Applicant Lenstec, Inc.

K number K161776

View details →

MSS 2016-07-06

Easy-Load Lens Delivery System

Applicant Bausch and Lomb, Inc.,

K number K161012

View details →

MSS 2013-12-27

EASY-LOAD LENS DELIVERY SYSTEM

Applicant Bausch & Lomb

K number K132481

View details →

MSS 2013-10-18

LENSTEC LC INJECTION SYSTEM

Applicant Lenstec, Inc.

K number K122848

View details →

MSS 2013-09-17

CRYSTALSERT DELIVERY SYSTEM

Applicant Bausch & Lomb

K number K132593

View details →

MSS 2013-05-16

CRYSTALSERT DELIVERY SYSTEM

Applicant Bausch & Lomb

K number K123736

View details →

MSS 2013-04-15

Z CARTRIDGE IOL DELIVERY SYSTEM

Applicant Aaren Scientific, Inc.

K number K123888

View details →

MSS 2012-09-28

BAUSCH & LOMB IOL INJECTOR

Applicant Bausch & Lomb, Inc.

K number K113852

View details →

MSS 2012-03-27

MONARCH III IOL DELIVERY SYSTEM, MONARCH III C CARTRIDGE, MONARCH III HANDPIECE (H4)

Applicant Alcon Research, Ltd.

K number K112977

View details →

MSS 2011-10-13

MONARCH III IOL DELIVERY SYSTEM; MONARCH III P CATRIDGE; MONARCH III HANDPIECE (H4)

Applicant Alcon Manufacturing, Ltd.

K number K101774

View details →

MSS 2011-06-29

ASICO SOFTIP INJECTOR SYSTEM

Applicant Asico, LLC

K number K103495

View details →

MSS 2010-12-22

MICROSTAAR MSI INJECTOR SYSTEM CARTRIDGE

Applicant Staar Japan

K number K101782

View details →

MSS 2010-08-09

VISIAN NANOPOINT 2.0 INJECTOR MODEL LP604430

Applicant Medicel AG

K number K101134

View details →

MSS 2009-12-04

RAYNER SMALL INCISION SINGLE USE SOFT TIPPED INJECTOR, MODEL R-INJ-04/18

Applicant Rayner Intraocular Lenses , Ltd.

K number K091507

View details →

MSS 2009-07-28

NAVIJECT SUB2-1P, MODEL: LP604430

Applicant Medicel AG

K number K092023

View details →

MSS 2009-07-09

XACT LENS INSERTER SYSTEM, MODELS 6MM, 7MM

Applicant Sis Ltd., Surgical Instrument Systems

K number K082871

View details →

MSS 2009-06-09

EPIPHANY INJECTION SYSTEM

Applicant Staar Surgical Co.

K number K090161

View details →

MSS 2009-03-23

HOYA IS INJECTOR SYSTEM

Applicant Hoya Surgical Optics, Inc.

K number K081346

View details →

MSS 2008-10-16

CRYSTALSERT CRYSTALENS DELIVERY SYSTEM

Applicant Bausch & Lomb, Inc.

K number K082944

View details →

MSS 2008-10-02

ONE SERIES ULTRA CARTRIDGE, MODEL 1VIPR30

Applicant Advanced Medical Optics, Inc.

K number K081545

View details →

MSS 2008-09-05

RAYNER SINGLE USE SMALL INCISION DISPOSABLE INJECTOR, MODEL R-INJ-06

Applicant Rayner Surgical, Inc.

K number K081455

View details →

MSS 2008-03-13

MICROSTAAR MSI INJECTOR FOAM TIP SYSTEM

Applicant Staar Surgical Co.

K number K073591

View details →

MSS 2008-03-13

MICROSTAAR INDIGO INJECTOR FOAM TIP SYSTEM

Applicant Staar Surgical Co.

K number K073586

View details →

MSS 2007-11-07

ROYALE AE 9036 LSP INJECTOR

Applicant Asico, LLC

K number K073010

View details →

MSS 2007-05-07

LENSTEC LC INJECTION SYSTEM

Applicant Lenstec, Inc.

K number K063802

View details →

MSS 2006-12-13

RAYNER SINGLE USE SOFT TIPPED DISPOSABLE INJECTOR, MODEL R-INJ-04

Applicant Rayner Surgical, Inc.

K number K062612

View details →

MSS 2006-05-22

DUCKWORTH & KENT LTD LENS DELIVERY SYSTEM, MODEL DK7788

Applicant Duckworth & Kent, Ltd.

K number K060995

View details →

MSS 2006-04-14

LENSTEC INTRAOCULAR LENS (IOL) INJECTION SYSTEM

Applicant Lenstec, Inc.

K number K060533

View details →

MSS 2006-01-30

DUCKWORTH & KENT LTD CARTRIDGE LENS DELIVERY SYSTEM, MODEL DK7797

Applicant Duckworth & Kent, Ltd.

K number K053176

View details →

MSS 2006-01-19

C-FLEX SYSTEM SINGLE USE DISPOSABLE INJECTOR, MODEL R-INJ-02

Applicant Rayner Surgical, Inc.

K number K052651

View details →

MSS 2005-05-31

LENSTEC INTRAOCULAR LENS (IOL) INJECTION SYSTEM FOR TETRAFLEX INTRAOCULAR LENSES

Applicant Lenstec, Inc.

K number K050638

View details →

MSS 2004-06-17

MULTIJECT INJECTOR AND MICROGLIDE CARTRIDGE

Applicant Medicel AG

K number K040837

View details →

MSS 2003-10-06

DUCKWORTH & KENT LTD LENS DELIVERY SYSTEM

Applicant Duckworth & Kent, Ltd.

K number K024072

View details →

MSS 2003-07-14

INJECTOR

Applicant Anton Meyer & Co. , Ltd.

K number K023737

View details →

MSS 2001-10-22

MICRA LENS INJECTOR, MICRA CARTRIDGE LENS, MICRA LENS LOADER

Applicant Micra Instruments

K number K011392

View details →

MSS 2001-01-05

MONARCH II IOL DELIVERY SYSTEM

Applicant Alcon Research, Ltd.

K number K003768

View details →

MSS 2000-10-31

CEEON EASYSERT INTRAOCULAR LENS INJECTOR, MODEL IMP-1

Applicant Pharmacia & Upjohn Co.

K number K002556

View details →

MSS 1998-09-11

FOAM TIP INJECTOR

Applicant Staar Surgical Co.

K number K980696

View details →

MSS 1997-12-17

MPORT FOLDABLE LENS PLACEMENT SYSTEM

Applicant Chiron Vision Corp.

K number K970727

View details →