Alcon Research, LLC

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
1053053	1053053	Alcon Research, LLC	1	Y	2026-01-01	11440 JOHNS CREEK PARKWAY DULUTH GA US 30097
1119421	1119421	Alcon Research, LLC	1	N	2026-01-01	246 KYLE LANE HUNTINGTON WV US 25702
1610287	1610287	Alcon Research, LLC	1	Y	2026-01-01	6201 SOUTH FREEWAY Fort Worth TX US 76134
1644019	1000117501	Alcon Research, LLC	1	Y	2026-01-01	9965 BUFFALO SPEEDWAY Houston TX US 77054
2028159	1000125771	Alcon Research, LLC	1	Y	2026-01-01	15800 Alton Pkwy IRVINE CA US 92618
2523835	2523835	Alcon Research, LLC	1	N	2026-01-01	714 COLUMBIA AVE. Sinking Spring PA US 19608
3007530141	3007530141	Alcon Research, LLC	1	N	2026-01-01	2 Vision Lane Lesage WV US 25537
3010208880	3010208880	Alcon Research, LLC	1	Y	2026-01-01	20511 Lake Forest Dr Lake Forest CA US 92630
3013497605	3013497605	Alcon Research, LLC	1	N	2026-01-01	700 Old Fritztown Rd Sinking Spring PA US 19608
1065835	3003027825	Alcon Research, LLC	1	N	2020-04-25	11440 JOHNS CREEK PARKWAY DULUTH GA US 30097

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
3069	1955590107	P990023	CELLUGEL(R) OPHTHALMIC VISCOSURGICAL DEVICE	LZP	2000-02-24
3069	1850471715	P950018	PERFLUORON (PURIFIED PERFLUORO-N-OCTANE LIQUID)	LWL	1996-02-29
3069	1712664779	P950008	SILIKON 1000	LWL	1997-09-25
3072	1846033250	P930014	ACRYSOF (R) UV ABSORBING INTRAOCULAR LENSES	HQL	1994-12-22
122221	1846033250	P930014	ACRYSOF (R) UV ABSORBING INTRAOCULAR LENSES	HQL	1994-12-22
3069	1983976184	P890047	PROVISC(TM)VISCOELASTIC PREPARATION	LZP	1991-09-26
3072	1593186575	P880087	KELMAN MULTIFLEX 2 MODELS: MT3-MT7 & MT2U-MT7U	HQL	1990-01-31
122221	1593186575	P880087	KELMAN MULTIFLEX 2 MODELS: MT3-MT7 & MT2U-MT7U	HQL	1990-01-31
3069	1061909259	P840064	VISCOAT(TM)/DVOVISC/DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICES	LZP	1986-04-30
3072	1566874706	P840060	SM-1, CR-1, & GR-1 IOLS	HQL	1986-04-30
122221	1566874706	P840060	SM-1, CR-1, & GR-1 IOLS	HQL	1986-04-30
3069	1159628693	P830034
3069	1086900385	P820001
3069	1517029564	P790011
3071	1200147224	P230012	UNIPURE SF6 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE SF6 Ophthalmic Gas in the UNIPEXY Gas Delivery Sy	LPO	2024-08-26
3071	1184656815	P220030	UNIPURE C3F8 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE C3F8 Ophthalmic Gas in the UNIPEXY Gas Delivery	LPO	2024-07-02
3069	1037317347	P220007	Precision7™; Precision7™ for Astigmatism; Precision7™ Multifocal; Precision7™ Multifocal Toric (serafilcon A) Soft Conta	LPM	2023-04-25
212890	1037317347	P220007	Precision7™; Precision7™ for Astigmatism; Precision7™ Multifocal; Precision7™ Multifocal Toric (serafilcon A) Soft Conta	LPM	2023-04-25
3069	1765131769	P190018	Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon Toric Aspheric Hydrophobic Acrylic Intraocular Lens	HQL	2020-01-07
3072	1765131769	P190018	Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon Toric Aspheric Hydrophobic Acrylic Intraocular Lens	HQL	2020-01-07
122221	1765131769	P190018	Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon Toric Aspheric Hydrophobic Acrylic Intraocular Lens	HQL	2020-01-07
3067	1847787500	P170034	HYDRUS MICROSTENT	OGO	2018-08-10
3067	1146478129	P150037	CyPass Micro-Stent	OGO	2016-07-29
3069	1146478129	P150037	CyPass Micro-Stent	OGO	2016-07-29
157573	1146478129	P150037	CyPass Micro-Stent	OGO	2016-07-29
3072	1102870917	P040020	ACRYSOF RESTOR APODIZED DIFFRACTIVE OPTIC POSTERIOR CHAMBER IOL	MFK	2005-03-21
122221	1102870917	P040020	ACRYSOF RESTOR APODIZED DIFFRACTIVE OPTIC POSTERIOR CHAMBER IOL	MFK	2005-03-21
3069	1106040295	P010059	MORCHER CAPSULAR TENSION RING, TYPES 14, 14A AND 14C	MRJ	2003-10-23
3069	1631213629	P010019	FOCUS NIGHT AND DAY (LOTRAFILCON A) SOFT CONTACT LENSES	LPM	2001-10-11
212890	1631213629	P010019	FOCUS NIGHT AND DAY (LOTRAFILCON A) SOFT CONTACT LENSES	LPM	2001-10-11
3069	1854834414	N13787	ENUCLENE CLEANING/LUBRICATING SOLUTION	MSI	1997-03-26
3069	2021737484	K984575	MULTI-PURPOSE DISINFECTING SOLUTION ID 90746	LPN	1999-01-14
3069	1039264167	K984573	OPTI-FREE EXPRESS MULTI-ACTION CLEANING AND REWETTING DROP	LPN	1999-09-16
3067	1250324879	K981571	MONARCH IOL DELIVERY SYSTEM	KYB	1998-07-09
3072	1250324879	K981571	MONARCH IOL DELIVERY SYSTEM	KYB	1998-07-09
122221	1250324879	K981571	MONARCH IOL DELIVERY SYSTEM	KYB	1998-07-09
3071	1157283630	K980292	CATARACT LIQUEFRACTURE DEVICE	MUS	1998-05-19
157573	1157283630	K980292	CATARACT LIQUEFRACTURE DEVICE	MUS	1998-05-19
3069	1311146877	K974625	OPTI-FREE SUPRACLENS DAILY PROTEIN REMOVER	LPN	1998-03-04
3069	2009748364	K974281	ALCON CONTACT LENS CASE	LRX	1998-01-20
3069	1819206663	K973332	ALCON MULTI-PURPOSE DISINFECTING SOLUTION ID 90746	LPN	1997-12-02
3069	1528935328	K971618	ALCON CONTACT LENS CASE	LRX	1997-07-14
3067	1027140355	K970033	MONARCH IOL DELIVERY SYSTEM	KYB	1997-04-23
3072	1027140355	K970033	MONARCH IOL DELIVERY SYSTEM	KYB	1997-04-23
122221	1027140355	K970033	MONARCH IOL DELIVERY SYSTEM	KYB	1997-04-23
3069	1707236327	K963487	DAILIES (NELFILCON A) ONE-DAY SOFT CONTACT LENS	LPL	1996-11-27
212890	1707236327	K963487	DAILIES (NELFILCON A) ONE-DAY SOFT CONTACT LENS	LPL	1996-11-27
212894	1707236327	K963487	DAILIES (NELFILCON A) ONE-DAY SOFT CONTACT LENS	LPL	1996-11-27
3071	1090659926	K962592	OPHTHALAS 532 SOLID STATE PHOTOCOAGULATOR, OR EQUIVALENT LASER SYSTEMS	GEX	1996-09-23
157573	1090659926	K962592	OPHTHALAS 532 SOLID STATE PHOTOCOAGULATOR, OR EQUIVALENT LASER SYSTEMS	GEX	1996-09-23
3067	1151012514	K952213	ALCON SERIES 20000 LEGACY PHACOEMULSIFIER	HQC	1995-08-09
3071	1151012514	K952213	ALCON SERIES 20000 LEGACY PHACOEMULSIFIER	HQC	1995-08-09
3074	1151012514	K952213	ALCON SERIES 20000 LEGACY PHACOEMULSIFIER	HQC	1995-08-09
157573	1151012514	K952213	ALCON SERIES 20000 LEGACY PHACOEMULSIFIER	HQC	1995-08-09
3071	1555278964	K946135	INFINITECH ASPIRATING LASER PROBE	HQE	1995-04-18
157573	1555278964	K946135	INFINITECH ASPIRATING LASER PROBE	HQE	1995-04-18
3071	1699895248	K934320	MENTOR WET-FIELD HEMOSTATIC ERASER BIPOLAR INSTRUMENT, 20 GAUGE WITH EXTRUSION ASPIRATION	HQR	1994-02-16
3074	1699895248	K934320	MENTOR WET-FIELD HEMOSTATIC ERASER BIPOLAR INSTRUMENT, 20 GAUGE WITH EXTRUSION ASPIRATION	HQR	1994-02-16
157573	1699895248	K934320	MENTOR WET-FIELD HEMOSTATIC ERASER BIPOLAR INSTRUMENT, 20 GAUGE WITH EXTRUSION ASPIRATION	HQR	1994-02-16
3067	1882775862	K930517	NON-ABSORBABLE SURGICAL SUTURES	GAR	1993-12-17
3071	1660136217	K930113	KIRWAN IRRIGATION/ASPIRATION HANDPIECE	HMX	1994-02-17
157573	1660136217	K930113	KIRWAN IRRIGATION/ASPIRATION HANDPIECE	HMX	1994-02-17
3071	1217402202	K925631	PHACOTRON GOLD MULTIFUNCTION ULTRASONIC HANDPIECE	HQC	1993-07-29
157573	1217402202	K925631	PHACOTRON GOLD MULTIFUNCTION ULTRASONIC HANDPIECE	HQC	1993-07-29
3071	1621683073	K921488	ASPIRATING ENDO OCULAR PROBE W/ILLUMINATION	HMX	1992-05-07
157573	1621683073	K921488	ASPIRATING ENDO OCULAR PROBE W/ILLUMINATION	HMX	1992-05-07
3071	1242937005	K914334	ALCON(R) FX2(TM) PHOTOCOAGULATOR	GEX	1992-11-13
157573	1242937005	K914334	ALCON(R) FX2(TM) PHOTOCOAGULATOR	GEX	1992-11-13
3067	1256789625	K911808	GEMINI OPHTHALMIC SURGERY SYSTEM	HQC	1991-06-25
3071	1256789625	K911808	GEMINI OPHTHALMIC SURGERY SYSTEM	HQC	1991-06-25
3074	1256789625	K911808	GEMINI OPHTHALMIC SURGERY SYSTEM	HQC	1991-06-25
157573	1256789625	K911808	GEMINI OPHTHALMIC SURGERY SYSTEM	HQC	1991-06-25
205356	1256789625	K911808	GEMINI OPHTHALMIC SURGERY SYSTEM	HQC	1991-06-25
3067	1625067110	K910245	I/A HANDPIECE WITH REPLACEABLE TIPS	GBX	1991-04-22
3071	1625067110	K910245	I/A HANDPIECE WITH REPLACEABLE TIPS	GBX	1991-04-22
157573	1625067110	K910245	I/A HANDPIECE WITH REPLACEABLE TIPS	GBX	1991-04-22
3071	1453399559	K897099	MODEL 2800 ND:YAG OPHTHALMIC LASER	GEX	1990-02-16
157573	1453399559	K897099	MODEL 2800 ND:YAG OPHTHALMIC LASER	GEX	1990-02-16
3067	1613813959	K896004	ALCON SURGICAL SPONGE	HOZ	1989-11-02
3071	1381083139	K890635	CAVITRON/KELMAN PHACOEMULSIFIER ASPIRATOR, UNIV.	HQC	1989-05-09
157573	1381083139	K890635	CAVITRON/KELMAN PHACOEMULSIFIER ASPIRATOR, UNIV.	HQC	1989-05-09
3071	1703620772	K890509	INDIRECT OPHTHALMOSCOPE ACCESSORY DELIVERY SYSTEM	HQF	1989-03-24
157573	1703620772	K890509	INDIRECT OPHTHALMOSCOPE ACCESSORY DELIVERY SYSTEM	HQF	1989-03-24
3069	1195929874	K890303	OPTI-TEARS(R)	LPN	1989-02-17
3069	1010970688	K880961	ALCON SURGICAL PROCEDURE PACKS	LRO	1988-04-29
3074	1010970688	K880961	ALCON SURGICAL PROCEDURE PACKS	LRO	1988-04-29
157573	1010970688	K880961	ALCON SURGICAL PROCEDURE PACKS	LRO	1988-04-29
3074	1109924004	K880863	BIPOLAR MICRO COAGULATOR MODELS 25-1000 & 25-1200	GEI	1988-04-19
3067	2036067121	K875005	PRISMA DISPOS. BRITE LITE FIBEROPTIC ENDOILLUMINA.	FST	1988-03-14
3071	2036067121	K875005	PRISMA DISPOS. BRITE LITE FIBEROPTIC ENDOILLUMINA.	FST	1988-03-14
3074	2036067121	K875005	PRISMA DISPOS. BRITE LITE FIBEROPTIC ENDOILLUMINA.	FST	1988-03-14
3071	1112523306	K871871	SERIES TEN THOUSAND OCUTOME	HQE	1987-06-11
3074	1112523306	K871871	SERIES TEN THOUSAND OCUTOME	HQE	1987-06-11
157573	1112523306	K871871	SERIES TEN THOUSAND OCUTOME	HQE	1987-06-11
3074	1503918297	K870942	MVS FIBEROPTIC LIGHTPIPE	FST	1987-04-03
157573	1503918297	K870942	MVS FIBEROPTIC LIGHTPIPE	FST	1987-04-03
3071	1720478384	K861380	SERIES TEN THOUSAND MASTER	HQE	1986-07-11
3074	1720478384	K861380	SERIES TEN THOUSAND MASTER	HQE	1986-07-11
157573	1720478384	K861380	SERIES TEN THOUSAND MASTER	HQE	1986-07-11
3074	1285143756	K851610	COMBINED MVS SYSTEMS	HQE	1985-07-22
157573	1285143756	K851610	COMBINED MVS SYSTEMS	HQE	1985-07-22
3071	1391413299	K844686	OPHTHASCAN B	IYO	1985-09-13
157573	1391413299	K844686	OPHTHASCAN B	IYO	1985-09-13
3071	1704399530	K843247	KOI PACHYMETER	ITX	1986-04-30
157573	1704399530	K843247	KOI PACHYMETER	ITX	1986-04-30
3071	1537702231	K842757	ULTRASCAN DIGITAL B	IYO	1985-01-09
157573	1537702231	K842757	ULTRASCAN DIGITAL B	IYO	1985-01-09
3071	1378592884	K834537	MICRO VIT FRAGMENTATION SYSTEM	HQC	1984-03-16
157573	1378592884	K834537	MICRO VIT FRAGMENTATION SYSTEM	HQC	1984-03-16
3074	1364400384	K831193	SCLERAL PLUG	LXP	1983-06-30
157573	1364400384	K831193	SCLERAL PLUG	LXP	1983-06-30
3069	1871864224	K830822	EYE DRAPE	HMT	1983-04-06
3074	1871864224	K830822	EYE DRAPE	HMT	1983-04-06
3069	1757425038	K820157	XOMED THERMAL MYRINGOTOMY SYSTEM	HQP	1982-03-02
3074	1757425038	K820157	XOMED THERMAL MYRINGOTOMY SYSTEM	HQP	1982-03-02

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
HQC	66	2024-06-21
LPL	49	2023-11-16
OOE	21	2025-09-24
HQE	15	2014-08-22
LPN	14	2019-07-31
KYB	12	2007-03-27
MVN	11	2020-09-22
MSS	9	2021-08-23
MLZ	7	2017-03-22
GEX	6	1996-09-23
HQL	6	1994-12-22
ORZ	5	2020-05-21
LRO	5	1988-04-29
FST	5	1988-03-14
OGO	4	2018-08-10
HQF	4	2007-11-05
HMX	4	1994-02-17
IYO	4	1985-09-13
MPA	3	2024-12-04
HQB	3	2011-10-17
LPM	3	2001-10-11
MRC	3	2000-07-03
HQR	3	1994-02-16
GBX	3	1991-04-22
HMT	3	1983-04-06
MFK	2	2005-03-21
MUS	2	1998-05-19
LRX	2	1998-01-20
LWL	2	1997-09-25
LZP	2	1991-09-26
ITX	2	1986-04-30
LXP	2	1983-06-30
HQP	2	1982-03-02
HKP	2	1979-10-30
HNN	1	2011-05-20
HJO	1	2010-11-03
MRJ	1	2003-10-23
KYF	1	2002-03-26
LZP	1	2000-02-24
GAR	1	1993-12-17

NDC#

Systane

Alcon Research Ltd

polyethylene glycol and propylene glycol

PMA#

AcrySof® IQ ReSTOR® Posterior Chamber Intraocular Lenses

2022-12-20

Alcon Research, Ltd.6201 South Freewayfort Worth, TX 76134-2099 PMA NumberP040020 Supplement NumberS104 Date Received11/22/2022 Decision Date12/20/2022 Product Code MFK Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Ch...

PROVISC™ Ophthalmic Viscosurgical

2022-09-15

Alcon Research, Ltd.6201 South Freeway, R3-48fort Worth, TX 76134-2099 PMA NumberP890047 Supplement NumberS059 Date Received08/23/2022 Decision Date09/15/2022 Product Code LZP Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Pro...

PROVISC™ Ophthalmic Viscosurgical

2022-09-13

Alcon Research, Ltd.6201 South Freeway, R3-48fort Worth, TX 76134-2099 PMA NumberP890047 Supplement NumberS058 Date Received08/17/2022 Decision Date09/13/2022 Product Code LZP Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Pro...

AcrySof IQ ReSTOR Posterior Chamber Intraocular Lenses

2022-05-18

Alcon Research, Ltd.6201 South Freewayfort Worth, TX 76134-2099 PMA NumberP040020 Supplement NumberS103 Date Received04/22/2022 Decision Date05/18/2022 Product Code MFK Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Ch...

AcrySof IQ ReSTOR Posterior Chamber Intraocular Lenses

2022-03-25

Alcon Research, Ltd.6201 South Freewayfort Worth, TX 76134-2099 PMA NumberP040020 Supplement NumberS102 Date Received03/01/2022 Decision Date03/25/2022 Product Code MFK Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Ch...

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