FDA.reportPublic FDA data

ALCON

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
10530531053053Alcon Research, LLC1Y2026-01-0111440 JOHNS CREEK PARKWAY DULUTH GA US 30097
11194211119421Alcon Research, LLC1N2026-01-01246 KYLE LANE HUNTINGTON WV US 25702
11212033000215259Alcon Vision, LLC1Y2026-01-016740 Business parkway Elkridge MD US 21075
16102871610287Alcon Research, LLC1Y2026-01-016201 SOUTH FREEWAY Fort Worth TX US 76134
16440191000117501Alcon Research, LLC1Y2026-01-019965 BUFFALO SPEEDWAY Houston TX US 77054
20281591000125771Alcon Research, LLC1Y2026-01-0115800 Alton Pkwy IRVINE CA US 92618
24108872410887ALCONOX, LLC1N2026-01-0130 GLENN ST., SUITE 309 White Plains NY US 10603
25238352523835Alcon Research, LLC1N2026-01-01714 COLUMBIA AVE. Sinking Spring PA US 19608
96121693002808262ALCON LABORATORIES IRELAND LTD.1N2026-01-01CORK BUSINESS AND TECHNOLOGY PARK MODEL FARM RD. CORK IE -
30071218163007121816Alcon (Puerto Rico) Inc.1Y2026-01-01Carr. 869, Km. 1.5 Royal Industrial Park, Building C Catano PR US 00962
30075301413007530141Alcon Research, LLC1N2026-01-012 Vision Lane Lesage WV US 25537
30102088803010208880Alcon Research, LLC1Y2026-01-0120511 Lake Forest Dr Lake Forest CA US 92630
30134976053013497605Alcon Research, LLC1N2026-01-01700 Old Fritztown Rd Sinking Spring PA US 19608
30154569513015456951Alcon Laboratories Belgium1N2026-01-01Lichterveld 3 Puurs-Sint-Amands Antwerpen BE 2870
10658353003027825Alcon Research, LLC1N2020-04-2511440 JOHNS CREEK PARKWAY DULUTH GA US 30097

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00300650193108OPTI-FREE EXPRESS - OPTI-FREE EXPRESS Rewetting Drops 10ml+1(800)241-5999web.masterus@alcon.com
00300650193207OPTI-FREE EXPRESS - OPTI-FREE EXPRESS Rewetting Drops 20ml+1(800)241-5999web.masterus@alcon.com
00380657410859Alcon, Infiniti, MicroSmooth, ABS - 0.9 mm 30° Round ABS® Tip+1(800)862-5266web.masterus@alcon.com
00380657410873Alcon, Infiniti, MicroSmooth, Kelman, ABS - 0.9 mm 30° Kelman® ABS® Tip+1(800)862-5266web.masterus@alcon.com
00380657410972Alcon, Infiniti, MicroSmooth, ABS - 1.1 mm 30° Round Flared ABS® Tip+1(800)862-5266web.masterus@alcon.com
00380657502806Alcon, Infiniti, MicroSmooth, ABS - 0.9 mm 30° Kelman® Tapered ABS® Tip+1(800)862-5266web.masterus@alcon.com
00380657517190Alcon, Infiniti, Intrepid, ABS - 0.9 mm 30° Ozil® 12 Mini-Flared ABS® Tip+1(800)862-5266web.masterus@alcon.com
00380657520886Alcon, Infiniti, Intrepid - 0.9 mm Tipless+1(800)862-5266web.masterus@alcon.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
30691955590107P990023CELLUGEL(R) OPHTHALMIC VISCOSURGICAL DEVICELZP2000-02-24
2271121955590107P990023CELLUGEL(R) OPHTHALMIC VISCOSURGICAL DEVICELZP2000-02-24
30691850471715P950018PERFLUORON (PURIFIED PERFLUORO-N-OCTANE LIQUID)LWL1996-02-29
30691712664779P950008SILIKON 1000LWL1997-09-25
30721846033250P930014ACRYSOF (R) UV ABSORBING INTRAOCULAR LENSESHQL1994-12-22
1222211846033250P930014ACRYSOF (R) UV ABSORBING INTRAOCULAR LENSESHQL1994-12-22
1753471846033250P930014ACRYSOF (R) UV ABSORBING INTRAOCULAR LENSESHQL1994-12-22
2271121846033250P930014ACRYSOF (R) UV ABSORBING INTRAOCULAR LENSESHQL1994-12-22
30691983976184P890047PROVISC(TM)VISCOELASTIC PREPARATIONLZP1991-09-26
2271121983976184P890047PROVISC(TM)VISCOELASTIC PREPARATIONLZP1991-09-26
30721593186575P880087KELMAN MULTIFLEX 2 MODELS: MT3-MT7 & MT2U-MT7UHQL1990-01-31
1222211593186575P880087KELMAN MULTIFLEX 2 MODELS: MT3-MT7 & MT2U-MT7UHQL1990-01-31
30691061909259P840064VISCOAT(TM)/DVOVISC/DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICESLZP1986-04-30
2271121061909259P840064VISCOAT(TM)/DVOVISC/DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICESLZP1986-04-30
30721566874706P840060SM-1, CR-1, & GR-1 IOLSHQL1986-04-30
1222211566874706P840060SM-1, CR-1, & GR-1 IOLSHQL1986-04-30
30691159628693P830034
30691086900385P820001
30691517029564P790011
30711200147224P230012UNIPURE SF6 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE SF6 Ophthalmic Gas in the UNIPEXY Gas Delivery SyLPO2024-08-26
30711184656815P220030UNIPURE C3F8 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE C3F8 Ophthalmic Gas in the UNIPEXY Gas DeliveryLPO2024-07-02
30691037317347P220007Precision7™; Precision7™ for Astigmatism; Precision7™ Multifocal; Precision7™ Multifocal Toric (serafilcon A) Soft ContaLPM2023-04-25
2128901037317347P220007Precision7™; Precision7™ for Astigmatism; Precision7™ Multifocal; Precision7™ Multifocal Toric (serafilcon A) Soft ContaLPM2023-04-25
30691765131769P190018Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon Toric Aspheric Hydrophobic Acrylic Intraocular LensHQL2020-01-07
30721765131769P190018Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon Toric Aspheric Hydrophobic Acrylic Intraocular LensHQL2020-01-07
1222211765131769P190018Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon Toric Aspheric Hydrophobic Acrylic Intraocular LensHQL2020-01-07
1753471765131769P190018Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon Toric Aspheric Hydrophobic Acrylic Intraocular LensHQL2020-01-07
2271121765131769P190018Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon Toric Aspheric Hydrophobic Acrylic Intraocular LensHQL2020-01-07
30671847787500P170034HYDRUS MICROSTENTOGO2018-08-10
30671146478129P150037CyPass Micro-StentOGO2016-07-29
30691146478129P150037CyPass Micro-StentOGO2016-07-29
1575731146478129P150037CyPass Micro-StentOGO2016-07-29
30721102870917P040020ACRYSOF RESTOR APODIZED DIFFRACTIVE OPTIC POSTERIOR CHAMBER IOLMFK2005-03-21
1222211102870917P040020ACRYSOF RESTOR APODIZED DIFFRACTIVE OPTIC POSTERIOR CHAMBER IOLMFK2005-03-21
1753471102870917P040020ACRYSOF RESTOR APODIZED DIFFRACTIVE OPTIC POSTERIOR CHAMBER IOLMFK2005-03-21
2271121102870917P040020ACRYSOF RESTOR APODIZED DIFFRACTIVE OPTIC POSTERIOR CHAMBER IOLMFK2005-03-21
30691106040295P010059MORCHER CAPSULAR TENSION RING, TYPES 14, 14A AND 14CMRJ2003-10-23
2271121106040295P010059MORCHER CAPSULAR TENSION RING, TYPES 14, 14A AND 14CMRJ2003-10-23
30691631213629P010019FOCUS NIGHT AND DAY (LOTRAFILCON A) SOFT CONTACT LENSESLPM2001-10-11
2128901631213629P010019FOCUS NIGHT AND DAY (LOTRAFILCON A) SOFT CONTACT LENSESLPM2001-10-11
30691854834414N13787ENUCLENE CLEANING/LUBRICATING SOLUTIONMSI1997-03-26
30692021737484K984575MULTI-PURPOSE DISINFECTING SOLUTION ID 90746LPN1999-01-14
30691039264167K984573OPTI-FREE EXPRESS MULTI-ACTION CLEANING AND REWETTING DROPLPN1999-09-16
30671250324879K981571MONARCH IOL DELIVERY SYSTEMKYB1998-07-09
30721250324879K981571MONARCH IOL DELIVERY SYSTEMKYB1998-07-09
1222211250324879K981571MONARCH IOL DELIVERY SYSTEMKYB1998-07-09
30711157283630K980292CATARACT LIQUEFRACTURE DEVICEMUS1998-05-19
1575731157283630K980292CATARACT LIQUEFRACTURE DEVICEMUS1998-05-19
30691311146877K974625OPTI-FREE SUPRACLENS DAILY PROTEIN REMOVERLPN1998-03-04
30692009748364K974281ALCON CONTACT LENS CASELRX1998-01-20
30691819206663K973332ALCON MULTI-PURPOSE DISINFECTING SOLUTION ID 90746LPN1997-12-02
30691528935328K971618ALCON CONTACT LENS CASELRX1997-07-14
30671027140355K970033MONARCH IOL DELIVERY SYSTEMKYB1997-04-23
30721027140355K970033MONARCH IOL DELIVERY SYSTEMKYB1997-04-23
1222211027140355K970033MONARCH IOL DELIVERY SYSTEMKYB1997-04-23
30691707236327K963487DAILIES (NELFILCON A) ONE-DAY SOFT CONTACT LENSLPL1996-11-27
2128901707236327K963487DAILIES (NELFILCON A) ONE-DAY SOFT CONTACT LENSLPL1996-11-27
2128941707236327K963487DAILIES (NELFILCON A) ONE-DAY SOFT CONTACT LENSLPL1996-11-27
30711090659926K962592OPHTHALAS 532 SOLID STATE PHOTOCOAGULATOR, OR EQUIVALENT LASER SYSTEMSGEX1996-09-23
1575731090659926K962592OPHTHALAS 532 SOLID STATE PHOTOCOAGULATOR, OR EQUIVALENT LASER SYSTEMSGEX1996-09-23
30671151012514K952213ALCON SERIES 20000 LEGACY PHACOEMULSIFIERHQC1995-08-09
30711151012514K952213ALCON SERIES 20000 LEGACY PHACOEMULSIFIERHQC1995-08-09
30741151012514K952213ALCON SERIES 20000 LEGACY PHACOEMULSIFIERHQC1995-08-09
1575731151012514K952213ALCON SERIES 20000 LEGACY PHACOEMULSIFIERHQC1995-08-09
30711555278964K946135INFINITECH ASPIRATING LASER PROBEHQE1995-04-18
1575731555278964K946135INFINITECH ASPIRATING LASER PROBEHQE1995-04-18
30711699895248K934320MENTOR WET-FIELD HEMOSTATIC ERASER BIPOLAR INSTRUMENT, 20 GAUGE WITH EXTRUSION ASPIRATIONHQR1994-02-16
30741699895248K934320MENTOR WET-FIELD HEMOSTATIC ERASER BIPOLAR INSTRUMENT, 20 GAUGE WITH EXTRUSION ASPIRATIONHQR1994-02-16
1575731699895248K934320MENTOR WET-FIELD HEMOSTATIC ERASER BIPOLAR INSTRUMENT, 20 GAUGE WITH EXTRUSION ASPIRATIONHQR1994-02-16
30671882775862K930517NON-ABSORBABLE SURGICAL SUTURESGAR1993-12-17
30711660136217K930113KIRWAN IRRIGATION/ASPIRATION HANDPIECEHMX1994-02-17
1575731660136217K930113KIRWAN IRRIGATION/ASPIRATION HANDPIECEHMX1994-02-17
30711217402202K925631PHACOTRON GOLD MULTIFUNCTION ULTRASONIC HANDPIECEHQC1993-07-29
1575731217402202K925631PHACOTRON GOLD MULTIFUNCTION ULTRASONIC HANDPIECEHQC1993-07-29
30711621683073K921488ASPIRATING ENDO OCULAR PROBE W/ILLUMINATIONHMX1992-05-07
1575731621683073K921488ASPIRATING ENDO OCULAR PROBE W/ILLUMINATIONHMX1992-05-07
30711242937005K914334ALCON(R) FX2(TM) PHOTOCOAGULATORGEX1992-11-13
1575731242937005K914334ALCON(R) FX2(TM) PHOTOCOAGULATORGEX1992-11-13
30671256789625K911808GEMINI OPHTHALMIC SURGERY SYSTEMHQC1991-06-25
30711256789625K911808GEMINI OPHTHALMIC SURGERY SYSTEMHQC1991-06-25
30741256789625K911808GEMINI OPHTHALMIC SURGERY SYSTEMHQC1991-06-25
1575731256789625K911808GEMINI OPHTHALMIC SURGERY SYSTEMHQC1991-06-25
2053561256789625K911808GEMINI OPHTHALMIC SURGERY SYSTEMHQC1991-06-25
2271121256789625K911808GEMINI OPHTHALMIC SURGERY SYSTEMHQC1991-06-25
30671625067110K910245I/A HANDPIECE WITH REPLACEABLE TIPSGBX1991-04-22
30711625067110K910245I/A HANDPIECE WITH REPLACEABLE TIPSGBX1991-04-22
1575731625067110K910245I/A HANDPIECE WITH REPLACEABLE TIPSGBX1991-04-22
30711453399559K897099MODEL 2800 ND:YAG OPHTHALMIC LASERGEX1990-02-16
1575731453399559K897099MODEL 2800 ND:YAG OPHTHALMIC LASERGEX1990-02-16
30671613813959K896004ALCON SURGICAL SPONGEHOZ1989-11-02
30711381083139K890635CAVITRON/KELMAN PHACOEMULSIFIER ASPIRATOR, UNIV.HQC1989-05-09
1575731381083139K890635CAVITRON/KELMAN PHACOEMULSIFIER ASPIRATOR, UNIV.HQC1989-05-09
30711703620772K890509INDIRECT OPHTHALMOSCOPE ACCESSORY DELIVERY SYSTEMHQF1989-03-24
1575731703620772K890509INDIRECT OPHTHALMOSCOPE ACCESSORY DELIVERY SYSTEMHQF1989-03-24
30691195929874K890303OPTI-TEARS(R)LPN1989-02-17
2271121303986311K884043GRIESHABER MICRO LITE LIGHT PIPE 19 & 20 GAUGEHQE1988-11-16
30691010970688K880961ALCON SURGICAL PROCEDURE PACKSLRO1988-04-29
30741010970688K880961ALCON SURGICAL PROCEDURE PACKSLRO1988-04-29
988001010970688K880961ALCON SURGICAL PROCEDURE PACKSLRO1988-04-29
1575731010970688K880961ALCON SURGICAL PROCEDURE PACKSLRO1988-04-29
30741109924004K880863BIPOLAR MICRO COAGULATOR MODELS 25-1000 & 25-1200GEI1988-04-19
30672036067121K875005PRISMA DISPOS. BRITE LITE FIBEROPTIC ENDOILLUMINA.FST1988-03-14
30712036067121K875005PRISMA DISPOS. BRITE LITE FIBEROPTIC ENDOILLUMINA.FST1988-03-14
30742036067121K875005PRISMA DISPOS. BRITE LITE FIBEROPTIC ENDOILLUMINA.FST1988-03-14
30711112523306K871871SERIES TEN THOUSAND OCUTOMEHQE1987-06-11
30741112523306K871871SERIES TEN THOUSAND OCUTOMEHQE1987-06-11
1575731112523306K871871SERIES TEN THOUSAND OCUTOMEHQE1987-06-11
30741503918297K870942MVS FIBEROPTIC LIGHTPIPEFST1987-04-03
1575731503918297K870942MVS FIBEROPTIC LIGHTPIPEFST1987-04-03
30711720478384K861380SERIES TEN THOUSAND MASTERHQE1986-07-11
30741720478384K861380SERIES TEN THOUSAND MASTERHQE1986-07-11
1575731720478384K861380SERIES TEN THOUSAND MASTERHQE1986-07-11
30741285143756K851610COMBINED MVS SYSTEMSHQE1985-07-22
1575731285143756K851610COMBINED MVS SYSTEMSHQE1985-07-22
30711391413299K844686OPHTHASCAN BIYO1985-09-13
1575731391413299K844686OPHTHASCAN BIYO1985-09-13

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HQC702024-06-21
LPL492023-11-16
OOE212025-09-24
HQE162014-08-22
LPN142019-07-31
KYB122007-03-27
MVN112020-09-22
MSS92021-08-23
HQL81994-12-22
MLZ72017-03-22
GEX61996-09-23
LRO61988-04-29
ORZ52020-05-21
FST51988-03-14
OGO42018-08-10
HQB42011-10-17
HQF42007-11-05
MFK42005-03-21
HMX41994-02-17
LZP41991-09-26
IYO41985-09-13
MPA32024-12-04
LPM32001-10-11
MRC32000-07-03
HQR31994-02-16
GBX31991-04-22
HMT31983-04-06
MRJ 22003-10-23
KYF22002-03-26
LZP 22000-02-24
MUS21998-05-19
LRX21998-01-20
LWL21997-09-25
ITX21986-04-30
LXP21983-06-30
HQP21982-03-02
HKP21979-10-30
HNN12011-05-20
HJO12010-11-03
GAR11993-12-17

NDC#

57 records. Showing 1-40. Next

PMA#

200 records. Showing 41-80. Previous Next

PMN#

126 records. Showing 1-40. Next

Applications#

50 records. Showing 1-40. Next

GUDID#

80 records. Showing 1-40. Next