Atlas FDA

MSS

63 FDA 510(k) clearances · Product code

105 daysmedian time to decision
274 days90th percentile
63clearances measured

FDA profile

Official device name
Folders And Injectors, Intraocular Lens (Iol)
Device class
Class I (low risk)
Regulation
21 CFR 886.4300
Medical specialty
Ophthalmic
Flags
Third-party review eligible
Adverse events (MAUDE)
2021: 289 · 2022: 490 · 2023: 330 · 2024: 375 · 2025: 436 · 2026: 316
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
RxSight® Insertion Device (K261174)Rxsight, Inc.2026-06-10
ACCUJECT Injector Set 2.1-1P (LP604590) (K252540)Medicel AG2025-09-16
EyeGility™ Inserter for Preloaded enVista IOLs (K242389)Bausch & Lomb, Incorporated2024-10-10
Accuject Refra Injector AR2900 (K231106)Medicel AG2023-09-19
RxSight® Insertion Device (63002) (K231838)Rxsight, Inc.2023-08-15
RxSight Insertion Device (K231466)Rxsight, Inc.2023-06-12
CLAREON MONARCH IV IOL Delivery System (K212039)Alcon Laboratories, Inc.2021-08-23
bioli lOL Delivery System (K200057)Ast Products, Inc.2020-06-04
RxSight Insertion Device (K192926)Rxsight, Inc.2020-01-17
Bausch + Lomb PreVue Inserter for enVista Preloaded (K192005)Bausch & Lomb, Inc.2019-10-04
UNFOLDER Vitan Inserter (K191949)Johnson & Johnson Surgical Vision, Inc.2019-09-13
BL-Cart IOL Delivery Cartridge (K182965)Ast Products, Inc.2019-03-29
RxSight Insertion Device (K181401)Rxsight, Inc.2018-07-26
pioli IOL Delivery System (K172228)Ast Products, Inc.2017-12-15
Crystalsert Lens Delivery System (K173480)Bausch & Lomb, Inc.2017-12-11
MicroSTAAR Injector System Cartridges (K172375)STAAR Surgical Company2017-09-06
Lenstec LC Injection system (K161776)Lenstec, Inc.2016-11-29
Easy-Load Lens Delivery System (K161012)Bausch and Lomb, Inc.,2016-07-06
Bausch + Lomb Injector System (K151102)Bausch & Lomb, Inc.2015-05-22
One Series ULTRA Cartridge, The UNFOLDER Platinum 1 Series (K143434)Abbott Medical Optics, Inc.2015-05-06
LIOLI IOL DELIVERY SYSTEM (K142056)Ast Products, Inc.2015-04-09
RaySert PLUS Injector, Single Use Soft Tipped Disposable Injector (K143307)Rayner Intraocular Lenses , Ltd.2014-12-18
RAYSERT PLUS INJECTOR (K141091)Rayner Intraocular Lenses , Ltd.2014-05-28
SINGLE USE SOFT TIPPED DISPOSABLE INJECTOR, RAYSERT SINGLE USE SOFT TIPPED SMALL INCISION DISPOSABLE INJECTOR (K132002)Rayner Intraocular Lenses , Ltd.2014-03-27
BAUSCH & LOMB INJECTOR SYSTEM (K131958)Bausch & Lomb2014-01-09
BAUSCH + LUMB, VIS100 INJECTOR SYSTEM (K133146)Bausch & Lomb2014-01-03
EASY-LOAD LENS DELIVERY SYSTEM (K132481)Bausch & Lomb2013-12-27
LENSTEC LC INJECTION SYSTEM (K122848)Lenstec, Inc.2013-10-18
CRYSTALSERT DELIVERY SYSTEM (K132593)Bausch & Lomb2013-09-17
CRYSTALSERT DELIVERY SYSTEM (K123736)Bausch & Lomb2013-05-16
Z CARTRIDGE IOL DELIVERY SYSTEM (K123888)Aaren Scientific, Inc.2013-04-15
BAUSCH & LOMB IOL INJECTOR (K113852)Bausch & Lomb, Inc.2012-09-28
MONARCH III IOL DELIVERY SYSTEM, MONARCH III C CARTRIDGE, MONARCH III HANDPIECE (H4) (K112977)Alcon Research, Ltd.2012-03-27
MONARCH III IOL DELIVERY SYSTEM; MONARCH III P CATRIDGE; MONARCH III HANDPIECE (H4) (K101774)Alcon Manufacturing, Ltd.2011-10-13
ASICO SOFTIP INJECTOR SYSTEM (K103495)Asico, LLC2011-06-29
MICROSTAAR MSI INJECTOR SYSTEM CARTRIDGE (K101782)Staar Japan2010-12-22
VISIAN NANOPOINT 2.0 INJECTOR MODEL LP604430 (K101134)Medicel AG2010-08-09
RAYNER SMALL INCISION SINGLE USE SOFT TIPPED INJECTOR, MODEL R-INJ-04/18 (K091507)Rayner Intraocular Lenses , Ltd.2009-12-04
NAVIJECT SUB2-1P, MODEL: LP604430 (K092023)Medicel AG2009-07-28
XACT LENS INSERTER SYSTEM, MODELS 6MM, 7MM (K082871)Sis Ltd., Surgical Instrument Systems2009-07-09
EPIPHANY INJECTION SYSTEM (K090161)Staar Surgical Co.2009-06-09
HOYA IS INJECTOR SYSTEM (K081346)Hoya Surgical Optics, Inc.2009-03-23
CRYSTALSERT CRYSTALENS DELIVERY SYSTEM (K082944)Bausch & Lomb, Inc.2008-10-16
ONE SERIES ULTRA CARTRIDGE, MODEL 1VIPR30 (K081545)Advanced Medical Optics, Inc.2008-10-02
RAYNER SINGLE USE SMALL INCISION DISPOSABLE INJECTOR, MODEL R-INJ-06 (K081455)Rayner Surgical, Inc.2008-09-05
MICROSTAAR MSI INJECTOR FOAM TIP SYSTEM (K073591)Staar Surgical Co.2008-03-13
MICROSTAAR INDIGO INJECTOR FOAM TIP SYSTEM (K073586)Staar Surgical Co.2008-03-13
ROYALE AE 9036 LSP INJECTOR (K073010)Asico, LLC2007-11-07
LENSTEC LC INJECTION SYSTEM (K063802)Lenstec, Inc.2007-05-07
RAYNER SINGLE USE SOFT TIPPED DISPOSABLE INJECTOR, MODEL R-INJ-04 (K062612)Rayner Surgical, Inc.2006-12-13
DUCKWORTH & KENT LTD LENS DELIVERY SYSTEM, MODEL DK7788 (K060995)Duckworth & Kent, Ltd.2006-05-22
LENSTEC INTRAOCULAR LENS (IOL) INJECTION SYSTEM (K060533)Lenstec, Inc.2006-04-14
DUCKWORTH & KENT LTD CARTRIDGE LENS DELIVERY SYSTEM, MODEL DK7797 (K053176)Duckworth & Kent, Ltd.2006-01-30
C-FLEX SYSTEM SINGLE USE DISPOSABLE INJECTOR, MODEL R-INJ-02 (K052651)Rayner Surgical, Inc.2006-01-19
LENSTEC INTRAOCULAR LENS (IOL) INJECTION SYSTEM FOR TETRAFLEX INTRAOCULAR LENSES (K050638)Lenstec, Inc.2005-05-31
MULTIJECT INJECTOR AND MICROGLIDE CARTRIDGE (K040837)Medicel AG2004-06-17
DUCKWORTH & KENT LTD LENS DELIVERY SYSTEM (K024072)Duckworth & Kent, Ltd.2003-10-06
INJECTOR (K023737)Anton Meyer & Co. , Ltd.2003-07-14
MICRA LENS INJECTOR, MICRA CARTRIDGE LENS, MICRA LENS LOADER (K011392)Micra Instruments2001-10-22
MONARCH II IOL DELIVERY SYSTEM (K003768)Alcon Research, Ltd.2001-01-05
CEEON EASYSERT INTRAOCULAR LENS INJECTOR, MODEL IMP-1 (K002556)Pharmacia & Upjohn Co.2000-10-31
FOAM TIP INJECTOR (K980696)Staar Surgical Co.1998-09-11
MPORT FOLDABLE LENS PLACEMENT SYSTEM (K970727)Chiron Vision Corp.1997-12-17

Track MSS automatically

Every clearance here is in the API, with alerts when new ones post.