FDA Product Code
FDA Product Code MSS — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Ophthalmic
- 21 CFR Citation
- 886.4300
510(k) Clearances — 63 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K261174 | RxSight® Insertion Device | Rxsight, Inc. | 2026-06-10 | Special | PDF ↗ |
| K252540 | ACCUJECT Injector Set 2.1-1P (LP604590) | Medicel AG | 2025-09-16 | Traditional | PDF ↗ |
| K242389 | EyeGility Inserter for Preloaded enVista IOLs | Bausch & Lomb, Incorporated | 2024-10-10 | Traditional | PDF ↗ |
| K231106 | Accuject Refra Injector AR2900 | Medicel AG | 2023-09-19 | Traditional | PDF ↗ |
| K231838 | RxSight® Insertion Device (63002) | Rxsight, Inc. | 2023-08-15 | Traditional | PDF ↗ |
| K231466 | RxSight Insertion Device | Rxsight, Inc. | 2023-06-12 | Special | PDF ↗ |
| K212039 | CLAREON MONARCH IV IOL Delivery System | Alcon Laboratories, Inc. | 2021-08-23 | Traditional | PDF ↗ |
| K200057 | bioli lOL Delivery System | Ast Products, Inc. | 2020-06-04 | Traditional | PDF ↗ |
| K192926 | RxSight Insertion Device | Rxsight, Inc. | 2020-01-17 | Traditional | PDF ↗ |
| K192005 | Bausch + Lomb PreVue Inserter for enVista Preloaded | Bausch & Lomb, Inc. | 2019-10-04 | Special | PDF ↗ |
| K191949 | UNFOLDER Vitan Inserter | Johnson & Johnson Surgical Vision, Inc. | 2019-09-13 | Abbreviated | PDF ↗ |
| K182965 | BL-Cart IOL Delivery Cartridge | Ast Products, Inc. | 2019-03-29 | Traditional | PDF ↗ |
| K181401 | RxSight Insertion Device | Rxsight, Inc. | 2018-07-26 | Traditional | PDF ↗ |
| K172228 | pioli IOL Delivery System | Ast Products, Inc. | 2017-12-15 | Traditional | PDF ↗ |
| K173480 | Crystalsert Lens Delivery System | Bausch & Lomb, Inc. | 2017-12-11 | Special | PDF ↗ |
| K172375 | MicroSTAAR Injector System Cartridges | STAAR Surgical Company | 2017-09-06 | Special | PDF ↗ |
| K161776 | Lenstec LC Injection system | Lenstec, Inc. | 2016-11-29 | Traditional | PDF ↗ |
| K161012 | Easy-Load Lens Delivery System | Bausch and Lomb, Inc., | 2016-07-06 | Special | PDF ↗ |
| K151102 | Bausch + Lomb Injector System | Bausch & Lomb, Inc. | 2015-05-22 | Special | PDF ↗ |
| K143434 | One Series ULTRA Cartridge, The UNFOLDER Platinum 1 Series | Abbott Medical Optics, Inc. | 2015-05-06 | Abbreviated | PDF ↗ |
| K142056 | LIOLI IOL DELIVERY SYSTEM | Ast Products, Inc. | 2015-04-09 | Traditional | PDF ↗ |
| K143307 | RaySert PLUS Injector, Single Use Soft Tipped Disposable Injector | Rayner Intraocular Lenses , Ltd. | 2014-12-18 | Special | PDF ↗ |
| K141091 | RAYSERT PLUS INJECTOR | Rayner Intraocular Lenses , Ltd. | 2014-05-28 | Special | PDF ↗ |
| K132002 | SINGLE USE SOFT TIPPED DISPOSABLE INJECTOR, RAYSERT SINGLE USE SOFT TIPPED SMALL INCISION DISPOSABLE INJECTOR | Rayner Intraocular Lenses , Ltd. | 2014-03-27 | Traditional | PDF ↗ |
| K131958 | BAUSCH & LOMB INJECTOR SYSTEM | Bausch & Lomb | 2014-01-09 | Traditional | PDF ↗ |
| K133146 | BAUSCH + LUMB, VIS100 INJECTOR SYSTEM | Bausch & Lomb | 2014-01-03 | Special | PDF ↗ |
| K132481 | EASY-LOAD LENS DELIVERY SYSTEM | Bausch & Lomb | 2013-12-27 | Traditional | PDF ↗ |
| K122848 | LENSTEC LC INJECTION SYSTEM | Lenstec, Inc. | 2013-10-18 | Traditional | PDF ↗ |
| K132593 | CRYSTALSERT DELIVERY SYSTEM | Bausch & Lomb | 2013-09-17 | Special | PDF ↗ |
| K123736 | CRYSTALSERT DELIVERY SYSTEM | Bausch & Lomb | 2013-05-16 | Traditional | PDF ↗ |
| K123888 | Z CARTRIDGE IOL DELIVERY SYSTEM | Aaren Scientific, Inc. | 2013-04-15 | Traditional | PDF ↗ |
| K113852 | BAUSCH & LOMB IOL INJECTOR | Bausch & Lomb, Inc. | 2012-09-28 | Traditional | PDF ↗ |
| K112977 | MONARCH III IOL DELIVERY SYSTEM, MONARCH III C CARTRIDGE, MONARCH III HANDPIECE (H4) | Alcon Research, Ltd. | 2012-03-27 | Abbreviated | PDF ↗ |
| K101774 | MONARCH III IOL DELIVERY SYSTEM; MONARCH III P CATRIDGE; MONARCH III HANDPIECE (H4) | Alcon Manufacturing, Ltd. | 2011-10-13 | Traditional | PDF ↗ |
| K103495 | ASICO SOFTIP INJECTOR SYSTEM | Asico, LLC | 2011-06-29 | Traditional | PDF ↗ |
| K101782 | MICROSTAAR MSI INJECTOR SYSTEM CARTRIDGE | Staar Japan | 2010-12-22 | Special | PDF ↗ |
| K101134 | VISIAN NANOPOINT 2.0 INJECTOR MODEL LP604430 | Medicel AG | 2010-08-09 | Traditional | PDF ↗ |
| K091507 | RAYNER SMALL INCISION SINGLE USE SOFT TIPPED INJECTOR, MODEL R-INJ-04/18 | Rayner Intraocular Lenses , Ltd. | 2009-12-04 | Traditional | PDF ↗ |
| K092023 | NAVIJECT SUB2-1P, MODEL: LP604430 | Medicel AG | 2009-07-28 | Special | PDF ↗ |
| K082871 | XACT LENS INSERTER SYSTEM, MODELS 6MM, 7MM | Sis Ltd., Surgical Instrument Systems | 2009-07-09 | Traditional | PDF ↗ |
| K090161 | EPIPHANY INJECTION SYSTEM | Staar Surgical Co. | 2009-06-09 | Traditional | PDF ↗ |
| K081346 | HOYA IS INJECTOR SYSTEM | Hoya Surgical Optics, Inc. | 2009-03-23 | Traditional | PDF ↗ |
| K082944 | CRYSTALSERT CRYSTALENS DELIVERY SYSTEM | Bausch & Lomb, Inc. | 2008-10-16 | Traditional | PDF ↗ |
| K081545 | ONE SERIES ULTRA CARTRIDGE, MODEL 1VIPR30 | Advanced Medical Optics, Inc. | 2008-10-02 | Traditional | PDF ↗ |
| K081455 | RAYNER SINGLE USE SMALL INCISION DISPOSABLE INJECTOR, MODEL R-INJ-06 | Rayner Surgical, Inc. | 2008-09-05 | Traditional | PDF ↗ |
| K073591 | MICROSTAAR MSI INJECTOR FOAM TIP SYSTEM | Staar Surgical Co. | 2008-03-13 | Traditional | PDF ↗ |
| K073586 | MICROSTAAR INDIGO INJECTOR FOAM TIP SYSTEM | Staar Surgical Co. | 2008-03-13 | Traditional | PDF ↗ |
| K073010 | ROYALE AE 9036 LSP INJECTOR | Asico, LLC | 2007-11-07 | Traditional | PDF ↗ |
| K063802 | LENSTEC LC INJECTION SYSTEM | Lenstec, Inc. | 2007-05-07 | Traditional | PDF ↗ |
| K062612 | RAYNER SINGLE USE SOFT TIPPED DISPOSABLE INJECTOR, MODEL R-INJ-04 | Rayner Surgical, Inc. | 2006-12-13 | Traditional | PDF ↗ |
| K060995 | DUCKWORTH & KENT LTD LENS DELIVERY SYSTEM, MODEL DK7788 | Duckworth & Kent, Ltd. | 2006-05-22 | Traditional | PDF ↗ |
| K060533 | LENSTEC INTRAOCULAR LENS (IOL) INJECTION SYSTEM | Lenstec, Inc. | 2006-04-14 | Traditional | PDF ↗ |
| K053176 | DUCKWORTH & KENT LTD CARTRIDGE LENS DELIVERY SYSTEM, MODEL DK7797 | Duckworth & Kent, Ltd. | 2006-01-30 | Traditional | PDF ↗ |
| K052651 | C-FLEX SYSTEM SINGLE USE DISPOSABLE INJECTOR, MODEL R-INJ-02 | Rayner Surgical, Inc. | 2006-01-19 | Traditional | PDF ↗ |
| K050638 | LENSTEC INTRAOCULAR LENS (IOL) INJECTION SYSTEM FOR TETRAFLEX INTRAOCULAR LENSES | Lenstec, Inc. | 2005-05-31 | Traditional | PDF ↗ |
| K040837 | MULTIJECT INJECTOR AND MICROGLIDE CARTRIDGE | Medicel AG | 2004-06-17 | Traditional | PDF ↗ |
| K024072 | DUCKWORTH & KENT LTD LENS DELIVERY SYSTEM | Duckworth & Kent, Ltd. | 2003-10-06 | Traditional | PDF ↗ |
| K023737 | INJECTOR | Anton Meyer & Co. , Ltd. | 2003-07-14 | Traditional | PDF ↗ |
| K011392 | MICRA LENS INJECTOR, MICRA CARTRIDGE LENS, MICRA LENS LOADER | Micra Instruments | 2001-10-22 | Traditional | PDF ↗ |
| K003768 | MONARCH II IOL DELIVERY SYSTEM | Alcon Research, Ltd. | 2001-01-05 | Abbreviated | PDF ↗ |
| K002556 | CEEON EASYSERT INTRAOCULAR LENS INJECTOR, MODEL IMP-1 | Pharmacia & Upjohn Co. | 2000-10-31 | Traditional | PDF ↗ |
| K980696 | FOAM TIP INJECTOR | Staar Surgical Co. | 1998-09-11 | Traditional | PDF ↗ |
| K970727 | MPORT FOLDABLE LENS PLACEMENT SYSTEM | Chiron Vision Corp. | 1997-12-17 | Traditional | PDF ↗ |
Product code MSS · Class I · Ophthalmic. Data: openFDA.