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.
Recent Cleared Devices (20 of 62)
Showing 20 most recent of 62 cleared devices.
| 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 |
Top Applicants
- Medicel AG — 5 clearances
- Lenstec, Inc. — 5 clearances
- Bausch & Lomb, Inc. — 5 clearances
- Bausch & Lomb — 5 clearances
- Staar Surgical Co. — 4 clearances
