Product code MSS
- Device name
- Folders And Injectors, Intraocular Lens (Iol)
- Medical specialty
- Ophthalmic
- Device class
- 1
- Regulation number
- 886.4300
- Review panel
- OP
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252540 | ACCUJECT Injector Set 2.1-1P (LP604590) | Medicel AG | 2025-09-16 |
| K242389 | EyeGility™ Inserter for Preloaded enVista IOLs | Bausch & Lomb, Incorporated | 2024-10-10 |
| K231106 | Accuject Refra Injector AR2900 | Medicel AG | 2023-09-19 |
| K231838 | RxSight® Insertion Device (63002) | Rxsight, Inc. | 2023-08-15 |
| K231466 | RxSight Insertion Device | Rxsight, Inc. | 2023-06-12 |
| K212039 | CLAREON MONARCH IV IOL Delivery System | Alcon Laboratories, Inc. | 2021-08-23 |
| K200057 | bioli lOL Delivery System | Ast Products, Inc. | 2020-06-04 |
| K192926 | RxSight Insertion Device | Rxsight, Inc. | 2020-01-17 |
| K192005 | Bausch + Lomb PreVue Inserter for enVista Preloaded | Bausch & Lomb, Inc. | 2019-10-04 |
| K191949 | UNFOLDER Vitan Inserter | Johnson & Johnson Surgical Vision, Inc. | 2019-09-13 |
| K182965 | BL-Cart IOL Delivery Cartridge | Ast Products, Inc. | 2019-03-29 |
| K181401 | RxSight Insertion Device | Rxsight, Inc. | 2018-07-26 |
| K172228 | pioli IOL Delivery System | Ast Products, Inc. | 2017-12-15 |
| K173480 | Crystalsert Lens Delivery System | Bausch & Lomb, Inc. | 2017-12-11 |
| K172375 | MicroSTAAR Injector System Cartridges | STAAR Surgical Company | 2017-09-06 |
| K161776 | Lenstec LC Injection system | Lenstec, Inc. | 2016-11-29 |
| K161012 | Easy-Load Lens Delivery System | Bausch and Lomb, Inc., | 2016-07-06 |
| K151102 | Bausch + Lomb Injector System | Bausch & Lomb, Inc. | 2015-05-22 |
| K143434 | One Series ULTRA Cartridge, The UNFOLDER Platinum 1 Series | Abbott Medical Optics, Inc. | 2015-05-06 |
| K142056 | LIOLI IOL DELIVERY SYSTEM | Ast Products, Inc. | 2015-04-09 |
| K143307 | RaySert PLUS Injector, Single Use Soft Tipped Disposable Injector | Rayner Intraocular Lenses , Ltd. | 2014-12-18 |
| K141091 | RAYSERT PLUS INJECTOR | Rayner Intraocular Lenses , Ltd. | 2014-05-28 |
| K132002 | SINGLE USE SOFT TIPPED DISPOSABLE INJECTOR, RAYSERT SINGLE USE SOFT TIPPED SMALL INCISION DISPOSABLE INJECTOR | Rayner Intraocular Lenses , Ltd. | 2014-03-27 |
| K131958 | BAUSCH & LOMB INJECTOR SYSTEM | Bausch & Lomb | 2014-01-09 |
| K133146 | BAUSCH + LUMB, VIS100 INJECTOR SYSTEM | Bausch & Lomb | 2014-01-03 |
| K132481 | EASY-LOAD LENS DELIVERY SYSTEM | Bausch & Lomb | 2013-12-27 |
| K122848 | LENSTEC LC INJECTION SYSTEM | Lenstec, Inc. | 2013-10-18 |
| K132593 | CRYSTALSERT DELIVERY SYSTEM | Bausch & Lomb | 2013-09-17 |
| K123736 | CRYSTALSERT DELIVERY SYSTEM | Bausch & Lomb | 2013-05-16 |
| K123888 | Z CARTRIDGE IOL DELIVERY SYSTEM | Aaren Scientific, Inc. | 2013-04-15 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10757770602497 | EyeGility™ Inserter | Bausch & Lomb Incorporated | 2026-04-05 |
| 10757770618115 | EyeGility™ Inserter | Bausch & Lomb Incorporated | 2026-04-05 |
| 10814899027454 | pioli™ IOL Delivery System | AST PRODUCTS, INC. | 2026-04-01 |
| 07630055212023 | ACCUJECT 2.2-1P INJECTOR SET | Medicel AG | 2025-12-09 |
| 07630055214584 | ACCUJECT injector Set 2.1-1P | Medicel AG | 2025-09-30 |
| 00818806021019 | RxSight Insertion Device | RXSIGHT, INC. | 2024-11-12 |
| 10818806021016 | RxSight Insertion Device | RXSIGHT, INC. | 2024-11-12 |
| 00844369018975 | CART45S | Lenstec Barbados Inc | 2024-05-06 |
| 00844369018968 | LC24 | Lenstec Barbados Inc | 2024-05-06 |
| 00844369018944 | LC16 | Lenstec Barbados Inc | 2024-05-06 |
| 00844369016872 | I9012FS | Lenstec Barbados Inc | 2024-05-06 |
| 00844369016865 | I9012 | Lenstec Barbados Inc | 2024-05-06 |
| 00844369016858 | I9011S | Lenstec Barbados Inc | 2024-05-06 |
| 20840311300024 | MicroStaar | STAAR SURGICAL COMPANY | 2023-06-15 |
| 20840311300017 | MicroStaar | STAAR SURGICAL COMPANY | 2023-06-15 |
| 00841668142851 | ASICO ROYALE III INJECTOR W/ LONG SPRING | KATENA PRODUCTS, INC. | 2022-12-13 |
| 00841668142868 | ASICO ROYALE III INJECTOR | KATENA PRODUCTS, INC. | 2022-12-13 |
| 00841668142905 | ASICO ROYALE II SPRING INJECTOR | KATENA PRODUCTS, INC. | 2022-12-13 |
| 00841668142943 | ASICO ROYALE III CLEANING INJECTOR | KATENA PRODUCTS, INC. | 2022-12-13 |
| 10814899027164 | bioli™ IOL Delivery System | AST PRODUCTS, INC. | 2022-10-03 |
| 10814899027133 | bioli™ IOL Delivery System | AST PRODUCTS, INC. | 2020-12-07 |
| 10814899027126 | bioli™ IOL Delivery System | AST PRODUCTS, INC. | 2020-12-07 |
| 10814899027072 | bioli™ IOL Delivery System | AST PRODUCTS, INC. | 2020-12-07 |
| 07630055222107 | NAVIJECT SUB2-1P INJECTOR SET | Medicel AG | 2020-10-21 |
| 07630055220080 | VISCOJECT 1.8 Injector set | Medicel AG | 2020-10-21 |
| 07630055220073 | VISCOJECT 2.2 INJECTOR-SET | Medicel AG | 2020-10-21 |
| 07630055220035 | NAVIJECT 2.6-3P INJECTOR-SET | Medicel AG | 2020-10-21 |
| 00380659777622 | MONARCH® | Alcon Laboratories, Inc. | 2020-05-20 |
| 10814899027065 | BL-Cart™ IOL Delivery Cartridge | AST PRODUCTS, INC. | 2019-10-04 |
| 05050474534605 | ONE SERIES ULTRA | JOHNSON & JOHNSON SURGICAL VISION, INC. | 2019-02-13 |