MSS · Folders And Injectors, Intraocular Lens (Iol)
Ophthalmic · 21 CFR 886.4300 · Class 1
Overview
| Product Code | MSS |
|---|---|
| Device Name | Folders And Injectors, Intraocular Lens (Iol) |
| Regulation | 21 CFR 886.4300 |
| Device Class | Class 1 |
| Review Panel | Ophthalmic |
| 3rd-Party Reviewable | Yes |
Identification
An intraocular lens guide is a device intended to be inserted into the eye during surgery to direct the insertion of an intraocular lens and be removed after insertion is completed.
Classification Rationale
Class I (general controls). Except when used as folders or injectors for soft or foldable intraocular lenses, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 886.9.
Cleared Devices (62)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K252540 | ACCUJECT Injector Set 2.1-1P (LP604590) | Medicel AG | Sep 16, 2025 | SESE |
| K242389 | EyeGility Inserter for Preloaded enVista IOLs | Bausch & Lomb, Incorporated | Oct 10, 2024 | SESE |
| K231106 | Accuject Refra Injector AR2900 | Medicel AG | Sep 19, 2023 | SESE |
| K231838 | RxSight® Insertion Device (63002) | Rxsight, Inc. | Aug 15, 2023 | SESE |
| K231466 | RxSight Insertion Device | Rxsight, Inc. | Jun 12, 2023 | SESE |
| K212039 | CLAREON MONARCH IV IOL Delivery System | Alcon Laboratories, Inc. | Aug 23, 2021 | SESE |
| K200057 | bioli lOL Delivery System | Ast Products, Inc. | Jun 4, 2020 | SESE |
| K192926 | RxSight Insertion Device | Rxsight, Inc. | Jan 17, 2020 | SESE |
| K192005 | Bausch + Lomb PreVue Inserter for enVista Preloaded | Bausch & Lomb, Inc. | Oct 4, 2019 | SESE |
| K191949 | UNFOLDER Vitan Inserter | Johnson & Johnson Surgical Vision, Inc. | Sep 13, 2019 | SESE |
| K182965 | BL-Cart IOL Delivery Cartridge | Ast Products, Inc. | Mar 29, 2019 | SESE |
| K181401 | RxSight Insertion Device | Rxsight, Inc. | Jul 26, 2018 | SESE |
| K172228 | pioli IOL Delivery System | Ast Products, Inc. | Dec 15, 2017 | SESE |
| K173480 | Crystalsert Lens Delivery System | Bausch & Lomb, Inc. | Dec 11, 2017 | SESE |
| K172375 | MicroSTAAR Injector System Cartridges | STAAR Surgical Company | Sep 6, 2017 | SESE |
| K161776 | Lenstec LC Injection system | Lenstec, Inc. | Nov 29, 2016 | SESE |
| K161012 | Easy-Load Lens Delivery System | Bausch and Lomb, Inc., | Jul 6, 2016 | SESE |
| K151102 | Bausch + Lomb Injector System | Bausch & Lomb, Inc. | May 22, 2015 | SESE |
| K143434 | One Series ULTRA Cartridge, The UNFOLDER Platinum 1 Series | Abbott Medical Optics, Inc. | May 6, 2015 | SESE |
| K142056 | LIOLI IOL DELIVERY SYSTEM | Ast Products, Inc. | Apr 9, 2015 | SESE |
| K143307 | RaySert PLUS Injector, Single Use Soft Tipped Disposable Injector | Rayner Intraocular Lenses , Ltd. | Dec 18, 2014 | SESE |
| K141091 | RAYSERT PLUS INJECTOR | Rayner Intraocular Lenses , Ltd. | May 28, 2014 | SESE |
| K132002 | SINGLE USE SOFT TIPPED DISPOSABLE INJECTOR, RAYSERT SINGLE USE SOFT TIPPED SMALL INCISION DISPOSABLE INJECTOR | Rayner Intraocular Lenses , Ltd. | Mar 27, 2014 | SESE |
| K131958 | BAUSCH & LOMB INJECTOR SYSTEM | Bausch & Lomb | Jan 9, 2014 | SESE |
| K133146 | BAUSCH + LUMB, VIS100 INJECTOR SYSTEM | Bausch & Lomb | Jan 3, 2014 | SESE |
| K132481 | EASY-LOAD LENS DELIVERY SYSTEM | Bausch & Lomb | Dec 27, 2013 | SESE |
| K122848 | LENSTEC LC INJECTION SYSTEM | Lenstec, Inc. | Oct 18, 2013 | SESE |
| K132593 | CRYSTALSERT DELIVERY SYSTEM | Bausch & Lomb | Sep 17, 2013 | SESE |
| K123736 | CRYSTALSERT DELIVERY SYSTEM | Bausch & Lomb | May 16, 2013 | SESE |
| K123888 | Z CARTRIDGE IOL DELIVERY SYSTEM | Aaren Scientific, Inc. | Apr 15, 2013 | SESE |
| K113852 | BAUSCH & LOMB IOL INJECTOR | Bausch & Lomb, Inc. | Sep 28, 2012 | SESE |
| K112977 | MONARCH III IOL DELIVERY SYSTEM, MONARCH III C CARTRIDGE, MONARCH III HANDPIECE (H4) | Alcon Research, Ltd. | Mar 27, 2012 | SESE |
| K101774 | MONARCH III IOL DELIVERY SYSTEM; MONARCH III P CATRIDGE; MONARCH III HANDPIECE (H4) | Alcon Manufacturing, Ltd. | Oct 13, 2011 | SESE |
| K103495 | ASICO SOFTIP INJECTOR SYSTEM | Asico, LLC | Jun 29, 2011 | SESE |
| K101782 | MICROSTAAR MSI INJECTOR SYSTEM CARTRIDGE | Staar Japan | Dec 22, 2010 | SESE |
| K101134 | VISIAN NANOPOINT 2.0 INJECTOR MODEL LP604430 | Medicel AG | Aug 9, 2010 | SESE |
| K091507 | RAYNER SMALL INCISION SINGLE USE SOFT TIPPED INJECTOR, MODEL R-INJ-04/18 | Rayner Intraocular Lenses , Ltd. | Dec 4, 2009 | SESE |
| K092023 | NAVIJECT SUB2-1P, MODEL: LP604430 | Medicel AG | Jul 28, 2009 | SESE |
| K082871 | XACT LENS INSERTER SYSTEM, MODELS 6MM, 7MM | Sis Ltd., Surgical Instrument Systems | Jul 9, 2009 | SESE |
| K090161 | EPIPHANY INJECTION SYSTEM | Staar Surgical Co. | Jun 9, 2009 | SESE |
| K081346 | HOYA IS INJECTOR SYSTEM | Hoya Surgical Optics, Inc. | Mar 23, 2009 | SESE |
| K082944 | CRYSTALSERT CRYSTALENS DELIVERY SYSTEM | Bausch & Lomb, Inc. | Oct 16, 2008 | SESE |
| K081545 | ONE SERIES ULTRA CARTRIDGE, MODEL 1VIPR30 | Advanced Medical Optics, Inc. | Oct 2, 2008 | SESE |
| K081455 | RAYNER SINGLE USE SMALL INCISION DISPOSABLE INJECTOR, MODEL R-INJ-06 | Rayner Surgical, Inc. | Sep 5, 2008 | SESE |
| K073591 | MICROSTAAR MSI INJECTOR FOAM TIP SYSTEM | Staar Surgical Co. | Mar 13, 2008 | SESE |
| K073586 | MICROSTAAR INDIGO INJECTOR FOAM TIP SYSTEM | Staar Surgical Co. | Mar 13, 2008 | SESE |
| K073010 | ROYALE AE 9036 LSP INJECTOR | Asico, LLC | Nov 7, 2007 | SESE |
| K063802 | LENSTEC LC INJECTION SYSTEM | Lenstec, Inc. | May 7, 2007 | SESE |
| K062612 | RAYNER SINGLE USE SOFT TIPPED DISPOSABLE INJECTOR, MODEL R-INJ-04 | Rayner Surgical, Inc. | Dec 13, 2006 | SESE |
| K060995 | DUCKWORTH & KENT LTD LENS DELIVERY SYSTEM, MODEL DK7788 | Duckworth & Kent, Ltd. | May 22, 2006 | SESE |
| K060533 | LENSTEC INTRAOCULAR LENS (IOL) INJECTION SYSTEM | Lenstec, Inc. | Apr 14, 2006 | SESE |
| K053176 | DUCKWORTH & KENT LTD CARTRIDGE LENS DELIVERY SYSTEM, MODEL DK7797 | Duckworth & Kent, Ltd. | Jan 30, 2006 | SESE |
| K052651 | C-FLEX SYSTEM SINGLE USE DISPOSABLE INJECTOR, MODEL R-INJ-02 | Rayner Surgical, Inc. | Jan 19, 2006 | SESE |
| K050638 | LENSTEC INTRAOCULAR LENS (IOL) INJECTION SYSTEM FOR TETRAFLEX INTRAOCULAR LENSES | Lenstec, Inc. | May 31, 2005 | SESE |
| K040837 | MULTIJECT INJECTOR AND MICROGLIDE CARTRIDGE | Medicel AG | Jun 17, 2004 | SESE |
| K024072 | DUCKWORTH & KENT LTD LENS DELIVERY SYSTEM | Duckworth & Kent, Ltd. | Oct 6, 2003 | SESE |
| K023737 | INJECTOR | Anton Meyer & Co. , Ltd. | Jul 14, 2003 | SESE |
| K011392 | MICRA LENS INJECTOR, MICRA CARTRIDGE LENS, MICRA LENS LOADER | Micra Instruments | Oct 22, 2001 | SESE |
| K003768 | MONARCH II IOL DELIVERY SYSTEM | Alcon Research, Ltd. | Jan 5, 2001 | SESE |
| K002556 | CEEON EASYSERT INTRAOCULAR LENS INJECTOR, MODEL IMP-1 | Pharmacia & Upjohn Co. | Oct 31, 2000 | SESE |
| K980696 | FOAM TIP INJECTOR | Staar Surgical Co. | Sep 11, 1998 | SESE |
| K970727 | MPORT FOLDABLE LENS PLACEMENT SYSTEM | Chiron Vision Corp. | Dec 17, 1997 | SESE |
Top Applicants
- Medicel AG — 5 clearances
- Lenstec, Inc. — 5 clearances
- Bausch & Lomb, Inc. — 5 clearances
- Bausch & Lomb — 5 clearances
- Staar Surgical Co. — 4 clearances
