MSS — Folders And Injectors, Intraocular Lens (Iol) Class I
FDA Device Classification
Classification Details
- Product Code
- MSS
- Device Class
- Class I
- Regulation Number
- 886.4300
- Submission Type
- Review Panel
- OP
- Medical Specialty
- Ophthalmic
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K252540 | medicel | ACCUJECT Injector Set 2.1-1P (LP604590) | September 16, 2025 |
| K242389 | bausch and lomb, incorporated | EyeGility Inserter for Preloaded enVista IOLs | October 10, 2024 |
| K231106 | medicel | Accuject Refra Injector AR2900 | September 19, 2023 |
| K231838 | rxsight | RxSight® Insertion Device (63002) | August 15, 2023 |
| K231466 | rxsight | RxSight Insertion Device | June 12, 2023 |
| K212039 | alcon laboratories | CLAREON MONARCH IV IOL Delivery System | August 23, 2021 |
| K200057 | ast products | bioli lOL Delivery System | June 4, 2020 |
| K192926 | rxsight | RxSight Insertion Device | January 17, 2020 |
| K192005 | bausch and lomb | Bausch + Lomb PreVue Inserter for enVista Preloaded | October 4, 2019 |
| K191949 | johnson and johnson surgical vision | UNFOLDER Vitan Inserter | September 13, 2019 |
| K182965 | ast products | BL-Cart IOL Delivery Cartridge | March 29, 2019 |
| K181401 | rxsight | RxSight Insertion Device | July 26, 2018 |
| K172228 | ast products | pioli IOL Delivery System | December 15, 2017 |
| K173480 | bausch and lomb | Crystalsert Lens Delivery System | December 11, 2017 |
| K172375 | staar surgical | MicroSTAAR Injector System Cartridges | September 6, 2017 |
| K161776 | lenstec | Lenstec LC Injection system | November 29, 2016 |
| K161012 | bausch and lomb, inc | Easy-Load Lens Delivery System | July 6, 2016 |
| K151102 | bausch and lomb | Bausch + Lomb Injector System | May 22, 2015 |
| K143434 | abbott medical optics | One Series ULTRA Cartridge, The UNFOLDER Platinum 1 Series | May 6, 2015 |
| K142056 | ast products | LIOLI IOL DELIVERY SYSTEM | April 9, 2015 |