FDA 510(k) Applications for Medical Device Product Code "MSS"
(Folders And Injectors, Intraocular Lens (Iol))
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K123888 | AAREN SCIENTIFIC, INC | Z CARTRIDGE IOL DELIVERY SYSTEM | 04/15/2013 |
| K143434 | ABBOTT MEDICAL OPTICS INC | One Series ULTRA Cartridge, The UNFOLDER Platinum 1 Series | 05/06/2015 |
| K081545 | ADVANCED MEDICAL OPTICS, INC. | ONE SERIES ULTRA CARTRIDGE, MODEL 1VIPR30 | 10/02/2008 |
| K212039 | ALCON LABORATORIES, INC. | CLAREON MONARCH IV IOL Delivery System | 08/23/2021 |
| K101774 | ALCON MANUFACTURING, LTD. | MONARCH III IOL DELIVERY SYSTEM; MONARCH III P CATRIDGE; MONARCH III HANDPIECE (H4) | 10/13/2011 |
| K003768 | ALCON RESEARCH, LTD. | MONARCH II IOL DELIVERY SYSTEM | 01/05/2001 |
| K112977 | ALCON RESEARCH, LTD. | MONARCH III IOL DELIVERY SYSTEM, MONARCH III C CARTRIDGE, MONARCH III HANDPIECE (H4) | 03/27/2012 |
| K023737 | ANTON MEYER & CO. LTD. | INJECTOR | 07/14/2003 |
| K103495 | ASICO LLC | ASICO SOFTIP INJECTOR SYSTEM | 06/29/2011 |
| K073010 | ASICO LLC | ROYALE AE 9036 LSP INJECTOR | 11/07/2007 |
| K200057 | AST Products, Inc. | bioli lOL Delivery System | 06/04/2020 |
| K182965 | AST Products, Inc. | BL-Cart IOL Delivery Cartridge | 03/29/2019 |
| K142056 | AST PRODUCTS, INC. | LIOLI IOL DELIVERY SYSTEM | 04/09/2015 |
| K172228 | AST Products, Inc. | pioli IOL Delivery System | 12/15/2017 |
| K131958 | BAUSCH & LOMB | BAUSCH & LOMB INJECTOR SYSTEM | 01/09/2014 |
| K133146 | BAUSCH & LOMB | BAUSCH + LUMB, VIS100 INJECTOR SYSTEM | 01/03/2014 |
| K123736 | BAUSCH & LOMB | CRYSTALSERT DELIVERY SYSTEM | 05/16/2013 |
| K132593 | BAUSCH & LOMB | CRYSTALSERT DELIVERY SYSTEM | 09/17/2013 |
| K132481 | BAUSCH & LOMB | EASY-LOAD LENS DELIVERY SYSTEM | 12/27/2013 |
| K192005 | Bausch & Lomb, Inc | Bausch + Lomb PreVue Inserter for enVista Preloaded | 10/04/2019 |
| K173480 | Bausch & Lomb, Inc | Crystalsert Lens Delivery System | 12/11/2017 |
| K113852 | BAUSCH & LOMB, INC. | BAUSCH & LOMB IOL INJECTOR | 09/28/2012 |
| K151102 | Bausch & Lomb, Inc. | Bausch + Lomb Injector System | 05/22/2015 |
| K082944 | BAUSCH & LOMB, INC. | CRYSTALSERT CRYSTALENS DELIVERY SYSTEM | 10/16/2008 |
| K161012 | Bausch and Lomb, Inc. | Easy-Load Lens Delivery System | 07/06/2016 |
| K970727 | CHIRON VISION CORP. | MPORT FOLDABLE LENS PLACEMENT SYSTEM | 12/17/1997 |
| K053176 | DUCKWORTH & KENT, LTD. | DUCKWORTH & KENT LTD CARTRIDGE LENS DELIVERY SYSTEM, MODEL DK7797 | 01/30/2006 |
| K024072 | DUCKWORTH & KENT, LTD. | DUCKWORTH & KENT LTD LENS DELIVERY SYSTEM | 10/06/2003 |
| K060995 | DUCKWORTH & KENT, LTD. | DUCKWORTH & KENT LTD LENS DELIVERY SYSTEM, MODEL DK7788 | 05/22/2006 |
| K081346 | HOYA SURGICAL OPTICS, INC. | HOYA IS INJECTOR SYSTEM | 03/23/2009 |
| K191949 | Johnson & Johnson Surgical Vision, Inc. | UNFOLDER Vitan Inserter | 09/13/2019 |
| K161776 | LENSTEC INC. | Lenstec LC Injection system | 11/29/2016 |
| K060533 | LENSTEC, INC. | LENSTEC INTRAOCULAR LENS (IOL) INJECTION SYSTEM | 04/14/2006 |
| K050638 | LENSTEC, INC. | LENSTEC INTRAOCULAR LENS (IOL) INJECTION SYSTEM FOR TETRAFLEX INTRAOCULAR LENSES | 05/31/2005 |
| K122848 | LENSTEC, INC. | LENSTEC LC INJECTION SYSTEM | 10/18/2013 |
| K063802 | LENSTEC, INC. | LENSTEC LC INJECTION SYSTEM | 05/07/2007 |
| K231106 | Medicel AG | Accuject Refra Injector AR2900 | 09/19/2023 |
| K040837 | MEDICEL AG | MULTIJECT INJECTOR AND MICROGLIDE CARTRIDGE | 06/17/2004 |
| K092023 | MEDICEL AG | NAVIJECT SUB2-1P, MODEL: LP604430 | 07/28/2009 |
| K101134 | MEDICEL AG | VISIAN NANOPOINT 2.0 INJECTOR MODEL LP604430 | 08/09/2010 |
| K011392 | MICRA INSTRUMENTS | MICRA LENS INJECTOR, MICRA CARTRIDGE LENS, MICRA LENS LOADER | 10/22/2001 |
| K002556 | PHARMACIA & UPJOHN CO. | CEEON EASYSERT INTRAOCULAR LENS INJECTOR, MODEL IMP-1 | 10/31/2000 |
| K091507 | RAYNER INTRAOCULAR LENSES LTD. | RAYNER SMALL INCISION SINGLE USE SOFT TIPPED INJECTOR, MODEL R-INJ-04/18 | 12/04/2009 |
| K141091 | RAYNER INTRAOCULAR LENSES LTD. | RAYSERT PLUS INJECTOR | 05/28/2014 |
| K143307 | RAYNER INTRAOCULAR LENSES LTD. | RaySert PLUS Injector, Single Use Soft Tipped Disposable Injector | 12/18/2014 |
| K132002 | RAYNER INTRAOCULAR LENSES LTD. | SINGLE USE SOFT TIPPED DISPOSABLE INJECTOR, RAYSERT SINGLE USE SOFT TIPPED SMALL INCISION DISPOSABLE INJECTOR | 03/27/2014 |
| K052651 | RAYNER SURGICAL INC | C-FLEX SYSTEM SINGLE USE DISPOSABLE INJECTOR, MODEL R-INJ-02 | 01/19/2006 |
| K081455 | RAYNER SURGICAL INC | RAYNER SINGLE USE SMALL INCISION DISPOSABLE INJECTOR, MODEL R-INJ-06 | 09/05/2008 |
| K062612 | RAYNER SURGICAL INC | RAYNER SINGLE USE SOFT TIPPED DISPOSABLE INJECTOR, MODEL R-INJ-04 | 12/13/2006 |
| K181401 | RxSight, Inc. | RxSight Insertion Device | 07/26/2018 |
| K192926 | RxSight, Inc. | RxSight Insertion Device | 01/17/2020 |
| K231466 | RxSight, Inc. | RxSight Insertion Device | 06/12/2023 |
| K231838 | RxSight, Inc. | RxSight« Insertion Device (63002) | 08/15/2023 |
| K082871 | SIS LTD. SURGICAL INSTRUMENT SYSTEMS | XACT LENS INSERTER SYSTEM, MODELS 6MM, 7MM | 07/09/2009 |
| K101782 | STAAR JAPAN | MICROSTAAR MSI INJECTOR SYSTEM CARTRIDGE | 12/22/2010 |
| K090161 | STAAR SURGICAL CO. | EPIPHANY INJECTION SYSTEM | 06/09/2009 |
| K980696 | STAAR SURGICAL CO. | FOAM TIP INJECTOR | 09/11/1998 |
| K073586 | STAAR SURGICAL CO. | MICROSTAAR INDIGO INJECTOR FOAM TIP SYSTEM | 03/13/2008 |
| K073591 | STAAR SURGICAL CO. | MICROSTAAR MSI INJECTOR FOAM TIP SYSTEM | 03/13/2008 |
| K172375 | STAAR Surgical Company | MicroSTAAR Injector System Cartridges | 09/06/2017 |
Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact
