Alcon Laboratories

FDA Filings

This page includes the latest FDA filings for Alcon Laboratories. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

FDA Owner/Operator Registration

FDA Filings

Device Company	Device	Date
NATACYN Eyevance Pharmaceuticals, LLC, Alcon Research LLC	Prescription Medication	2023-10-10
NATACYN Eyevance Pharmaceuticals, LLC, Alcon Research LLC	Prescription Medication	2022-11-17
NATACYN Eyevance Pharmaceuticals, LLC, Alcon Research LLC	Prescription Medication	2022-11-03
NATACYN Eyevance Pharmaceuticals, LLC, Alcon Research LLC	Prescription Medication	2022-08-11
PMA P840064S076 ALCON LABORATORIES	DISCOVISC Ophthalmic Viscosurgical	2021-12-03
PMA P840064S075 ALCON LABORATORIES	DISCOVISC™ Ophthalmic Viscosurgical	2021-12-03
PMA P880087S031 ALCON LABORATORIES	Single-Piece PMMA Anterior Chamber IOLs	2021-12-02
PMA P840060S049 ALCON LABORATORIES	Single-Piece PMMA Posterior Chamber IOL	2021-12-02
NATACYN Eyevance Pharmaceuticals, LLC, Alcon Research LLC	Prescription Medication	2021-12-01
PMA P950018S020 ALCON LABORATORIES	Perfluoron	2021-11-23
NATACYN Eyevance Pharmaceuticals, LLC, Alcon Research LLC	Prescription Medication	2021-06-15
PMA P840064S074 ALCON LABORATORIES	VISCOAT Ophthalmic Viscoelastic System, DUOVISC Ophthalmic Viscoelastic System (consists of PRIVSC and VISCOAT)	2021-03-03
PMA P880087S030 ALCON LABORATORIES	PMMA Single-Piece Anterior Chamber Intraocular Lens	2020-12-17
PMA P840060S048 ALCON LABORATORIES	PMMA Single-Piece Posterior Chamber Intraocular Lens	2020-12-17
PMA P840064S073 ALCON LABORATORIES	VISCOAT Ophthalmic Viscoelastic System, DUOVISC Ophthalmic Viscoelastic System (consists of PROVISC and VISCOAT), and DI	2020-10-23
PMA P840064S072 ALCON LABORATORIES	VISCOAT Ophthalmic Viscoelastic System and DUOVISC Ophthalmic Viscoelastic System	2020-09-16
PMA P950018S019 ALCON LABORATORIES	PERFLUORON	2020-07-24
PMA P840064S071 ALCON LABORATORIES	DUOVISC Ophthalmic Viscoelastic System (consists of PROVISC and VISCOAT), DISCOVISC Ophthalmic Viscosurgical	2020-04-02
PMA P880087S029 ALCON LABORATORIES	PMMA Single-Piece Anterior Chamber Intraocular Lens	2019-08-01
PMA P840060S047 ALCON LABORATORIES	PMMA Single-Piece Posterior Chamber Intraocular Lens	2019-08-01
PMA P810032S070 ALCON LABORATORIES	PMMA Multi-Piece Posterior Chamber Intraocular Lens	2019-08-01
PMA P880087S028 ALCON LABORATORIES	PMMA Single-Piece Anterior Chamber Intraocular Lenses	2019-04-22
PMA P880087S027 ALCON LABORATORIES	PMMA Single-Piece Anterior Chamber Intraocular Lens	2019-04-22
PMA P840060S046 ALCON LABORATORIES	PMMA Single-Piece Posterior Chamber Intraocular Lenses	2019-04-22
PMA P840060S045 ALCON LABORATORIES	PMMA Single-Piece Posterior Chamber Intraocular Lens	2019-04-22
PMA P810032S069 ALCON LABORATORIES	PMMA Multi-Piece Posterior Chamber Intraocular Lenses	2019-04-22
PMA P810032S068 ALCON LABORATORIES	PMMA Multi-Piece Posterior Chamber Intraocular Lens	2019-04-22
PMA P840064S070 ALCON LABORATORIES	Ophthalmic Viscosurgical s	2019-03-20
PMA P840064S069 ALCON LABORATORIES	VISCOAT/DUOVISC Ophthalmic Viscoelastic System	2018-06-28
PMA P840064S068 ALCON LABORATORIES	VISCOAT Opthalmic Viscoelastic System, DUOVISC Opthalmic Viscoelastic System	2018-04-24
PMA P840064S067 ALCON LABORATORIES	Duovisc, Viscoat, Discovisc Ophthalmic Viscosurgical s	2017-11-01
PMA P840064S062 ALCON LABORATORIES	VISCOAT OPHTHALMIC VISCOSURGICAL DEVICE; DUOVISC OPHTHALMIC VISCOSURGICAL DEVICE (WITH PROVISC IN LATEX-FREE PACK)	2017-10-31
PMA P840064S064 ALCON LABORATORIES	OPHTHALMIC VICOSURGICAL DEVICE (OVD)	2017-10-25
PMA P840064S066 ALCON LABORATORIES	Ophthalmic Viscosurgical s	2017-05-18
PMN K062624 ALCON LABORATORIES	NEXT GENERATION LASER	2007-11-05
PMN K062865 ALCON LABORATORIES	SMALL VOLUME SYRINGE	2007-08-23
PMN K000148 ALCON LABORATORIES	RGP MULTI-PURPOSE SOLUTION ID 100136	2000-04-11
PMN K984573 ALCON LABORATORIES	OPTI-FREE EXPRESS MULTI-ACTION CLEANING AND REWETTING DROP	1999-09-16
PMN K990480 ALCON LABORATORIES	OPTI-FREE SUPRACLENS DAILY PROTEIN REMOVER	1999-05-10
PMN K984575 ALCON LABORATORIES	MULTI-PURPOSE DISINFECTING SOLUTION ID 90746	1999-01-14
PMN K983973 ALCON LABORATORIES	OPTI-ONE MULTI-PURPOSE SOLUTION	1998-12-18
PMN K983780 ALCON LABORATORIES	MULTI-PURPOSE DISINFECTING SOLUTION ID 90746	1998-12-18
PMN K981561 ALCON LABORATORIES	LIQUID ENZYME ID 90133	1998-07-24
PMN K981571 ALCON LABORATORIES	MONARCH IOL DELIVERY SYSTEM	1998-07-09
PMN K981103 ALCON LABORATORIES	TURBOSONICS LIMITED REUSE ULTRASONIC TIP	1998-06-23
PMN K981151 ALCON LABORATORIES	OPTI-FREE SUPRACLENS DAILY PROTEIN REMOVER/ALCON WETTING, SOAKING, CONDITIONING AND DISINFECTING SOLUTION ID 84392	1998-06-22
PMN K980292 ALCON LABORATORIES	CATARACT LIQUEFRACTURE DEVICE	1998-05-19
PMN K974625 ALCON LABORATORIES	OPTI-FREE SUPRACLENS DAILY PROTEIN REMOVER	1998-03-04
PMN K974624 ALCON LABORATORIES	ALCON MULTI-PURPOSE DISINFECTING SOLUTION ID 90746	1998-03-04
PMN K974281 ALCON LABORATORIES	ALCON CONTACT LENS CASE	1998-01-20
PMN K973332 ALCON LABORATORIES	ALCON MULTI-PURPOSE DISINFECTING SOLUTION ID 90746	1997-12-02
PMN K971618 ALCON LABORATORIES	ALCON CONTACT LENS CASE	1997-07-14
PMN K970033 ALCON LABORATORIES	MONARCH IOL DELIVERY SYSTEM	1997-04-23
PMN K965185 ALCON LABORATORIES	ACRYPAK FOLDER	1997-03-31
PMN K962592 ALCON LABORATORIES	OPHTHALAS 532 SOLID STATE PHOTOCOAGULATOR, OR EQUIVALENT LASER SYSTEMS	1996-09-23
PMN K955789 ALCON LABORATORIES	ALCON SERIES 20000 LEGACY MACKOOL SYSTEM	1996-03-21
PMN K952213 ALCON LABORATORIES	ALCON SERIES 20000 LEGACY PHACOEMULSIFIER	1995-08-09
PMN K932062 ALCON LABORATORIES	OPHTHALAS 532 SOLID STATE PHOTOCOAGULATOR	1994-03-18
PMN K930517 ALCON LABORATORIES	NON-ABSORBABLE SURGICAL SUTURES	1993-12-17
PMN K931620 ALCON LABORATORIES	OPTI-FREE CONTACT LENS CASE	1993-06-28
PMN K914334 ALCON LABORATORIES	ALCON(R) FX2(TM) PHOTOCOAGULATOR	1992-11-13
PMN K920641 ALCON LABORATORIES	ALCON OPERATING MICROSCOPES	1992-10-09
PMN K911587 ALCON LABORATORIES	K-SOL(TM)	1991-11-01
PMN K912130 ALCON LABORATORIES	TBD KERATOSCOPE	1991-08-09
PMN K912134 ALCON LABORATORIES	TBD, LENS MEASURING DEVICE	1991-07-25
PMN K911808 ALCON LABORATORIES	GEMINI OPHTHALMIC SURGERY SYSTEM	1991-06-25
PMN K895434 ALCON LABORATORIES	ALCON FOLDING FORCEPS	1989-12-04
PMN K896004 ALCON LABORATORIES	ALCON SURGICAL SPONGE	1989-11-02
PMN K885230 ALCON LABORATORIES	MCDONALD FOLDING FORCEPS	1989-05-17
PMN K890303 ALCON LABORATORIES	OPTI-TEARS(R)	1989-02-17
PMN K882723 ALCON LABORATORIES	ALCON FLUID INJECTOR	1988-11-08
PMN K881682 ALCON LABORATORIES	ALCON SITE(R)-COMPATIBLE CASSETTE	1988-07-01
PMN K880961 ALCON LABORATORIES	ALCON SURGICAL PROCEDURE PACKS	1988-04-29
PMN K873548 ALCON LABORATORIES	OPTI-ZYME(R)	1987-09-29
PMN K873099 ALCON LABORATORIES	MANUAL OPHTHALMIC SURGICAL INSTRUMENTS	1987-09-04
PMN K854159 ALCON LABORATORIES	ELLIPTI-PUNCH	1985-11-15
PMN K822104 ALCON LABORATORIES	ALCON INDIRECT OPHTHALMOSCOPE	1982-08-10
PMN K812172 ALCON LABORATORIES	CONTACT LENS CLEANER	1981-08-31
PMN K760696 ALCON LABORATORIES	REMOTE CONTROL SYSTEM FOR MICROSCOPE	1976-12-16
PMN K760697 ALCON LABORATORIES	EVANS ARM AND HAND REST	1976-11-02
PMN K760158 ALCON LABORATORIES	NEEDLES AND SUTURES, SILK & NYLON	1976-08-19

Similar & Related FDA Registered Companies

ALCON Laboratories Inc.
ALCON RESEARCH, LTD. DBA ALCON LABORATORIES, INC.
ALCON LABORATORIES, INC.6201 South Freeway Dr.fort Worth, TX 76134 PMA NumberP930014 Supplement NumberS144 Date Received11/22/2022 Decision Date12/20/2022 Product Code HQL Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Alcon Laboratories, LLC6201 South Freewayfort Worth, TX 76134 PMA NumberP190018 Supplement NumberS021 Date Received11/22/2022 Decision Date12/20/2022 Product Codes MJP HQL Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
ALCON LABORATORIES6201 South Freewayfort Worth, TX 76134 PMA NumberP990023 Supplement NumberS018 Date Received08/24/2022 Decision Date09/22/2022 Product Code LZP Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
ALCON LABORATORIES6201 S Freewayft Worth, TX 76134 PMA NumberP840064 Supplement NumberS078 Date Received08/23/2022 Decision Date09/15/2022 Product Code LZP Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
ALCON LABORATORIES6201 South Freewayfort Worth, TX 76134 PMA NumberP990023 Supplement NumberS017 Date Received08/23/2022 Decision Date09/15/2022 Product Code LZP Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
ALCON LABORATORIES6201 S Freewayft Worth, TX 76134 PMA NumberP840064 Supplement NumberS077 Date Received08/17/2022 Decision Date09/13/2022 Product Code LZP Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
ALCON LABORATORIES6201 South Freeway R3-48fort Worth, TX 76134 PMA NumberP950018 Supplement NumberS021 Date Received07/18/2022 Decision Date08/12/2022 Product Code LWL Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Alcon Laboratories, Inc.6201 South Freewayfort Worth, TX 76134-2099 PMA NumberP010019 Supplement NumberS083 Date Received06/09/2022 Decision Date07/06/2022 Product Code LPM Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Alcon Laboratories, LLC6201 South Freewayfort Worth, TX 76134 PMA NumberP190018 Supplement NumberS020 Date Received04/22/2022 Decision Date05/18/2022 Product Codes HQL MJP Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
ALCON LABORATORIES, INC.6201 South Freeway Dr.fort Worth, TX 76134 PMA NumberP930014 Supplement NumberS143 Date Received04/22/2022 Decision Date05/18/2022 Product Code HQL Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Alcon Laboratories, LLC6201 South Freewayfort Worth, TX 76134 PMA NumberP190018 Supplement NumberS019 Date Received04/06/2022 Decision Date05/03/2022 Product Codes MJP HQL Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
ALCON LABORATORIES, INC.6201 South Freeway Dr.fort Worth, TX 76134 PMA NumberP930014 Supplement NumberS142 Date Received03/01/2022 Decision Date03/25/2022 Product Code HQL Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Eyevance Pharmaceuticals, LLC
Alcon Research LLC

Related Finance Registrations

NCAGE Code	0MJ70	ALCON LABORATORIES
NCAGE Code	ZH288	ALCON LABORATORIES
CAGE Code	0MJ70	ALCON LABORATORIES
CAGE Code	ZH288	ALCON LABORATORIES

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020092512949	Stadersand,Federal Republic of Germany -> Savannah, Georgia	FOILS HS CODE 39219060	17 PKG
2020092416613	Stadersand,Federal Republic of Germany -> Savannah, Georgia	FOILS HS CODE 39219060	17 PKG
2020091929359	Stadersand,Federal Republic of Germany -> Savannah, Georgia	FOILS HS CODE 39219060	17 PKG
202009095060	Bremerhaven,Federal Republic of Germany -> Savannah, Georgia	FOIL HS CODE 39219060	20 PKG
2020090978613	Stadersand,Federal Republic of Germany -> Savannah, Georgia	FOILS HS CODE 39219060	17 PKG
2020083153610	Bremerhaven,Federal Republic of Germany -> Savannah, Georgia	20 PACKAGES FOIL HS-CODE 39219060	20 PKG
2020081345914	Bremerhaven,Federal Republic of Germany -> Savannah, Georgia	FOIL HS CODE 39219060	20 PKG
2020081154786	Bremerhaven,Federal Republic of Germany -> Savannah, Georgia	FOIL HS CODE 39219060	20 PKG