MSS · Class I · 21 CFR 886.4300

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

Leading manufacturers include Medicel AG, Lenstec, Inc. and Rxsight, Inc..

63
Total
63
Cleared
129d
Avg days
1997
Since
Declining activity - 2 submissions in the last 2 years vs 4 in the prior period
Review times improving: avg 49d recently vs 132d historically

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

63 devices
1–24 of 63
Cleared Jun 10, 2026
RxSight® Insertion Device
K261174
Rxsight, Inc.
Ophthalmic · 62d
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 15, 2017
pioli IOL Delivery System
K172228
Ast Products, Inc.
Ophthalmic · 143d
Cleared Dec 11, 2017
Crystalsert Lens Delivery System
K173480
Bausch & Lomb, Inc.
Ophthalmic · 28d
Cleared Sep 06, 2017
MicroSTAAR Injector System Cartridges
K172375
STAAR Surgical Company
Ophthalmic · 30d
Cleared Nov 29, 2016
Lenstec LC Injection system
K161776
Lenstec, Inc.
Ophthalmic · 153d
Cleared Jul 06, 2016
Easy-Load Lens Delivery System
K161012
Bausch and Lomb, Inc.,
Ophthalmic · 86d
Cleared May 22, 2015
Bausch + Lomb Injector System
K151102
Bausch & Lomb, Inc.
Ophthalmic · 28d
Cleared May 06, 2015
One Series ULTRA Cartridge, The UNFOLDER Platinum 1 Series
K143434
Abbott Medical Optics, Inc.
Ophthalmic · 156d
Cleared Apr 09, 2015
LIOLI IOL DELIVERY SYSTEM
K142056
Ast Products, Inc.
Ophthalmic · 254d
Cleared Dec 18, 2014
RaySert PLUS Injector, Single Use Soft Tipped Disposable Injector
K143307
Rayner Intraocular Lenses , Ltd.
Ophthalmic · 30d
Cleared May 28, 2014
RAYSERT PLUS INJECTOR
K141091
Rayner Intraocular Lenses , Ltd.
Ophthalmic · 30d
Cleared Mar 27, 2014
SINGLE USE SOFT TIPPED DISPOSABLE INJECTOR, RAYSERT SINGLE USE SOFT TIPPED SMALL INCISION DISPOSABLE INJECTOR
K132002
Rayner Intraocular Lenses , Ltd.
Ophthalmic · 269d

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 declined in recent years - 2 submissions in the last 24 months compared to 4 in the prior period.

FDA 510(k) Review Time - MSS Product Code

Recent submissions under MSS have taken an average of 49 days to reach a decision - down from 132 days historically, suggesting improved FDA processing for this classification.

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