MSS · Class I · 21 CFR 886.4300

FDA Product Code MSS: Folders And Injectors, Intraocular Lens (iol)

Leading manufacturers include Bausch & Lomb, Inc., Rxsight, Inc. and Ast Products, Inc..

63
Total
63
Cleared
129d
Avg days
1997
Since
Stable submission activity - 3 submissions in the last 2 years
Review times improving: avg 52d recently vs 133d historically

FDA 510(k) Cleared Folders And Injectors, Intraocular Lens (iol) Devices (Product Code MSS)

63 devices
1–24 of 63
Cleared Sep 16, 2025
ACCUJECT Injector Set 2.1-1P (LP604590)
K252540
Medicel AG
Ophthalmic · 35d
Cleared Oct 10, 2024
EyeGility™ Inserter for Preloaded enVista IOLs
K242389
Bausch & Lomb, Incorporated
Ophthalmic · 59d
Cleared Sep 19, 2023
Accuject Refra Injector AR2900
K231106
Medicel AG
Ophthalmic · 153d
Cleared Aug 15, 2023
RxSight® Insertion Device (63002)
K231838
Rxsight, Inc.
Ophthalmic · 54d
Cleared Jun 12, 2023
RxSight Insertion Device
K231466
Rxsight, Inc.
Ophthalmic · 24d
Cleared Aug 23, 2021
CLAREON MONARCH IV IOL Delivery System
K212039
Alcon Laboratories, Inc.
Ophthalmic · 54d
Cleared Jun 04, 2020
bioli lOL Delivery System
K200057
Ast Products, Inc.
Ophthalmic · 143d
Cleared Jan 17, 2020
RxSight Insertion Device
K192926
Rxsight, Inc.
Ophthalmic · 93d
Cleared Oct 04, 2019
Bausch + Lomb PreVue Inserter for enVista Preloaded
K192005
Bausch & Lomb, Inc.
Ophthalmic · 67d
Cleared Sep 13, 2019
UNFOLDER Vitan Inserter
K191949
Johnson & Johnson Surgical Vision, Inc.
Ophthalmic · 53d
Cleared Mar 29, 2019
BL-Cart IOL Delivery Cartridge
K182965
Ast Products, Inc.
Ophthalmic · 155d
Cleared Jul 26, 2018
RxSight Insertion Device
K181401
Rxsight, Inc.
Ophthalmic · 58d
Cleared Dec 11, 2017
Crystalsert Lens Delivery System
K173480
Bausch & Lomb, Inc.
Ophthalmic · 28d
Cleared May 22, 2015
Bausch + Lomb Injector System
K151102
Bausch & Lomb, Inc.
Ophthalmic · 28d
Cleared Sep 28, 2012
BAUSCH & LOMB IOL INJECTOR
K113852
Bausch & Lomb, Inc.
Ophthalmic · 274d
Cleared Oct 16, 2008
CRYSTALSERT CRYSTALENS DELIVERY SYSTEM
K082944
Bausch & Lomb, Inc.
Ophthalmic · 14d

About Product Code MSS - Regulatory Context

510(k) Submission Activity

63 total 510(k) submissions under product code MSS since 1997, with 63 receiving FDA clearance (average review time: 129 days).

Submission volume has remained relatively stable over the observed period, with 3 submissions in the last 24 months.

FDA 510(k) Review Time - MSS Product Code

Recent submissions under MSS have taken an average of 52 days to reach a decision - down from 133 days historically, suggesting improved FDA processing for this classification.

MSS devices are reviewed by the Ophthalmic panel. Browse all Ophthalmic devices →