Alcon Research, LLC

FDA Device Registration & Listing · Houston, TX, US · Registration 1644019

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1644019
FEI Number
1000117501
Entity Name
Alcon Research, LLC
City/State/Country
Houston, TX, US
Establishment Address
9965 BUFFALO SPEEDWAY, Houston, TX 77054, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Alcon Laboratories, Inc. (Owner Number: 1610287)
Owner / Operator Contact Address
6201 South Freeway, Fort Worth, TX 76134, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K141065
PMA Number
N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HQF Laser, Ophthalmic Ophthalmic Class 2 886.4390 2024-07-01
HQE Instrument, Vitreous Aspiration And Cutting, Ac-Powered Ophthalmic Class 2 886.4150 2024-07-01
HQC Unit, Phacofragmentation Ophthalmic Class 2 886.4670 2024-07-01
HMT Drape, Patient, Ophthalmic General, Plastic Surgery Class 2 878.4370 2008-11-20
QDY Vitrectomy Kit Ophthalmic Class 2 886.4150 2024-02-07
LRO General Surgery Tray General, Plastic Surgery Class 2 878.4370 2007-12-13
PZG Surgical Eye Tray Ophthalmic Class 1 886.4350 2024-02-07
HQC Unit, Phacofragmentation Ophthalmic Class 2 886.4670 2019-11-13
NGY Cannula, Trocar, Ophthalmic Ophthalmic Class 1 886.4350 2009-04-16
OJK Eye Tray Ophthalmic Class 2 886.4790 2024-02-07
KYB Lens, Guide, Intraocular Ophthalmic Class 1 886.4300 2012-04-19
HQR Apparatus, Cautery, Radiofrequency, Ac-Powered Ophthalmic Class 2 886.4100 2012-04-19
MLZ Vitrectomy, Instrument Cutter Ophthalmic Class 2 886.4150 2012-04-19
HQC Unit, Phacofragmentation Ophthalmic Class 2 886.4670 2012-04-19
OOE Ophthalmic Femtosecond Laser Ophthalmic Class 2 886.4390 2021-01-04
HNO Keratome, Ac-Powered Ophthalmic Class 1 886.4370 2021-01-04
HQC Unit, Phacofragmentation Ophthalmic Class 2 886.4670 2021-01-04
MLZ Vitrectomy, Instrument Cutter Ophthalmic Class 2 886.4150 2011-12-14
HMT Drape, Patient, Ophthalmic General, Plastic Surgery Class 2 878.4370 2018-05-23
QDW Phaco Kit Ophthalmic Class 2 886.4670 2024-02-07
HQC Unit, Phacofragmentation Ophthalmic Class 2 886.4670 2015-11-06
HQE Instrument, Vitreous Aspiration And Cutting, Ac-Powered Ophthalmic Class 2 886.4150 2015-11-06

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Alcon Laboratories, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3013497605 Alcon Research, LLC Sinking Spring, PA, US
3003701944 OPTONOL, LTD NEVE ILAN Central, IL
3016232028 LUMITHERA, INC. Fort Worth, TX, US
3006186389 CIBA VISION JOHOR SDN.BHD., GELANG PATAH, JOHOR DARUL TAKZIM, MY
3016075957 IVANTIS, INC. Irvine, CA, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K191650 Alcon Research, LLC LEGION System 2019-11-01
K834060 F. & F. Koenigkramer RELIANCE OPHTHALMIC SLIT LAMP R-083 1984-02-04
K091915 Lenstec, Inc. FLUID ISOLATION DEVICE 2009-10-27
K830812 Alphamedix, Inc. ALPHAMEDIX I/A HAND-PIECE, 500-001 1983-06-08
K133115 Abbott Medical Optics, Inc. COMPACT INTUITIV; SYSTEM, WIRELESS REMOTE CONTROL, FOUR-BUTTON FOOT PEDAL, SINGLE-USE FLUIDICS PACK 2014-02-27

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0095-2021 Alcon Research, LLC 2
Alcon Custom-Pak Surgical Procedure Packs containing Cardinal Health" PROTEXIS" Latex Micro Surgical Gloves - Product Usage: used by ophthalmic surgeons in a variety of ophthalmic surgeries.
Z-0260-2024 Alcon Research, LLC 2
Alcon Custom-Pak, Surgical Procedure Pack REF 14057-09, 45K W/DUOVISC CATARACT, N VIRGINIA EYE SURG CTR
Z-0354-2023 Alcon Research, LLC 2
Alcon Custom Pak Surgical Procedure Pack
Z-1291-2023 Alcon Research, LLC 2
Alcon Custom Pak Surgical Procedure Pack: Pak Number & Pak Description: 17533-04 DR GROSS LPS LLC 18704-03 CATARACT SURGI CARE 18382-03 DR GEORGE ZAMBELLI BEAVER VALLEY ASC 8685-21 CATARACT PACK EYE SURGICAL CNTR OF AR 19451-02 DR ROESKE PACK INLAND VALLEY SURGERY CTR 19136-03 OCCULOPLASTIC WILMINGTON EYE 18401-03 MCGRAW SIGHTPATH MEDICAL 16032-05 MIDDLE TENNESSEE PACK SIGHTPATH MEDICAL 17570-05 CATARACT CENTURION FORT MADISON COMM HOS 19002-02 CATARACT BAPTIST HEALTH SURGERY CENTER 10560-14 CATARACT - NORTH CENTRAL 1 SIGHTPATH MED 16877-11 DR DAVID B LEACH CLEARVIEW SURGERY CENTE 19061-02 HOSLER UNIVERSITY SURGI CENTER 18911-02 MASON CATARACT THE ASC AT UNITED MEDICAL 17469-02 GENERAL CUSTOM PACK SHARP MEMORIAL HOSPI 18917-01 CATARACT 2 SURGERY CENTER OF THE TEMECUL 17115-06 DR SCZEPANSKI NORTH DAKOTA EYE CLINIC 17780-04 OPHTHALMIC TEXAS PRECISION SURGERY CENTE 2452-58 CATARACT BOLSA OUTPATIENT SURG CTR 19096-01 OPHTHALMIC EAST ALABAMA AMB SURGERY CENT 18023-04 OPHTHALMIC BRAINARD SURGERY CENTER 17039-13 EYE-Q COMPLETE CAT PAK VISION CARE SURG 5300-61 CATARACT WOODLAND MEM HOSP
Z-1328-2021 Alcon Research, LLC 2
Alcon Custom Ophthalmic Surgical Procedure Packs
Z-1370-2024 Alcon Research, LLC 2
SYRINGE,BULB,2OZ/60CC,GREEN, Part: 300055070, packaged inside Alcon Custom-Pak Surgical Procedure Packs, Products: 18018-06, 3865-44, 5675-76, 13554-11, 18018-06, 15190-16 , 15190-16, 15190-16, 15190-16, 15190-16, 13554-11, 5918-39, 15190-16, 15190-16, 9208-66, 9208-66, 5675-76, 5918-39, 9208-66, 15190-16, 9065-25, 5918-39, 16066-15, 16066-15
Z-1373-2022 Alcon Research, LLC 2
Alcon Custom Pak Surgical Procedure Pack: 16998-11 2519351H SALAHUDDIN 2.4 PACK FRESNO SURGICAL HOSP 18392-03 14HDFF CATARACT SWAGEL WOOTTON EYE INSTITUTE 18527-03 14JM57 DOSS CATARACT ALLIANCE EYE SURG PARTNERS 11802-07 14KFAF GANS BASIC PACK NOVAMED EYE SURG CTR 11802-07 14LTRW GANS BASIC PACK NOVAMED EYE SURG CTR 11802-07 14LLME GANS BASIC PACK NOVAMED EYE SURG CTR 14429-07 14HPW3 DR SIEMINSKI CATARACT W NY CTR/AMB SVCS
Z-1606-2024 Alcon Research, LLC 2
Various Alcon Custom Paks Surgical Procedure Pack containing Oasis 27Ga Chang Hydrodissection Cannulas. These Custom Paks are surgical procedure packs used by ophthalmic surgeons in a variety of ophthalmic surgeries. The Custom Pak is a collection of various ophthalmic surgical instruments and necessary materials. Below are the various Alcon Customer Paks and Pak REF Numbers: 0515-66 ELMENDORF AFB CATARACT 3RD MED CTR 0752-74 CATARACT V A MED CTR 1119-82 DR DAVID B LEACH PALOUSE SURGERY CENTER 11401-13 CATARACT SUTTER SOLANO MED CTR 11910-32 DAVISON-SAGGAU CATARACT WOLFE EYE SURGER 11912-26 30 DEG CATARACT BASE PACK WOLFE EYE SUR 11913-23 JOHNSON CATARACT WOLFE EYE SURGERY CENTE 12185-14 CATARACT LASERVUE EYE CENTER 12213-12 CATARACT TULSA SPINE AND SPECIALTY 12213-13 CATARACT TULSA SPINE AND SPECIALTY 12213-15 CATARACT TULSA SPINE AND SPECIALTY 12213-16 CATARACT TULSA SPINE AND SPECIALTY 12643-06 CATARACT PACK OCHSNER BAPTIST MED CTR 12931-17 JOHNSON CATARACT GREATER COMMUNITY HOSP 12942-18 CONRAD PHYSICIANS MEDICAL CENTER 12942-19 CONRAD PHYSICIANS MEDICAL CENTER 13567-10 OPHTHALMIC PHYSICIANS SURG CTR 13948-15 DR RHEE PACK MARSHALLTOWN MED/SURG CNT 13970-11 CATARACT GWINNETT CTR OUTPT SURG 13970-12 CATARACT GWINNETT CTR OUTPT SURG 14389-08 INFINITI STAMFORD SURGICAL CENTER 14408-12 E-Z PACK QUEEN OF THE VALLEY 14408-13 E-Z PACK QUEEN OF THE VALLEY 14533-18 OPHTHALMIC UOFL HOSPITAL 15209-05 CATARACT NORTH ATLANTA EYE SURGERY CTR 15354-16 DR RAUEN WOLFE EYE SURGERY CENTER LLC 15435-13 EPS 2.2 PACK IOWA CITY AMBULATORY SURGER 15502-10 DR NEWCOMB LEXINGTON CLINIC 15639-12 DR RAUEN LUCAS COUNTY HEALTH CTR 15678-13 DR RAUEN CLARKE COUNTY HOSPITAL 15965-12 DR LEVAR CHRISTUS SANTA ROSA ASC 16001-12 DR YONKER/BESCAK CESC 16001-13 DR YONKER/BESCAK CESC 16013-12 DR MCDONALD NORTH FL SURG PAVILION 16086-07 DR DAVID B LEACH PULLMAN MEMORIAL HOSPIT 16177-08 OPHTHALMIC DENVER EYE SURG CTR 16204-13 CATARACT V A HOSPITAL 16450-10 DR GROSS/GUSSLER KINGS DAUGHTERS HOSPITA 16452-06 RAECKER PACK GREATER COMMUNITY HOSP 16633-08 CATARACT DUOVISC RETINA SPECIALISTS NJ 16644-08 DR BALES HOSPITAL PACK NATIVE INVESTMENT 16644-09 DR BALES HOSPITAL PACK NATIVE INVESTMENT 16798-08 CATARACT HAUSER ROSS EYE INSTITUTE 16820-06 PHACO LONE PEAK SURGERY CENTER 17029-09 DR ICON CATARACT DAY SURGERY OF GRAND JU 17201-18 SILVERA VALLEY SURGERY CENTER 17340-08 EPS 2.2 PACK WASHINGTON COUNTY HOSP 17354-07 EPS 2.2 PACK HENRY COUNTY HEALTH CTR 17361-08 MICRO PAK CARLE FOUNDATION HOSP 17382-05 CATARACT BILLINGS VA MEDICAL CENTE 17382-07 CATARACT BILLINGS VA MEDICAL CENTE 17507-02 DR CAMPAGNA NORTH CENTRAL METH ASC 17520-05 DR GROSS CHARLESTON SURGERY CTR 17526-09 CPK0926-CROSBY-DONG-GADLIN-JAC VANTAGE O 17529-09 CPK0927 AESC VANTAGE OUTSOURCING 17541-07 HAIDER DUPONT SURG CTR 17541-08 HAIDER DUPONT SURG CTR 17617-05 DR CHUNG CATARACT PACK ST HELENA HOSPITA 17651-06 DMEK-DSEK-CAT CENTER FOR ADVANCED SURGER 17653-06 DR HUNT CHARLESTON AREA MED CTR 17671-06 CATARACT EDMONDS CENTER FOR OUTPAT 17671-07 CATARACT EDMONDS CENTER FOR OUTPAT 17740-06 DR ESPANDAR ARMSTRONG CO MEM HOSP 17740-07 DR ESPANDAR ARMSTRONG CO MEM HOSP 17740-08 DR ESPANDAR ARMSTRONG CO MEM HOSP 17773-09 DR ESPANDAR JAMESON MEMORIAL HOSPITAL 17930-08 CATARACT PACK NORTHERN PLAINS SURG CTR 17966-06 TURNER CATARACT WOLFE EYE SURGERY CENTER 17987-05 OPHTHALMIC SEATTLE SURGERY CENTER 18069-04 DR WENTWORTH CATARACT GREENVIEW SURGERY 18123-05 CATARACT BOWERS INNOVATIVE EYE SURGERY C 18208-09 CATARACT SUTTER FAIRFIELD SURG CTR 18382-04 DR GEORGE ZAMBELLI BEAVER VALLEY ASC 18382-06 DR GEORGE ZAMBELLI BEAVER VALLEY ASC 18384-04 DR BURKS SPRINGHILL SURGERY CENTER 18401-04 MCGRAW SIGHTPATH MEDICAL 18406-03 DR KUCHINKA HAYWARD AREA HOSP 18427-07 CATARACT V A HOSPITAL 18427-08 CATARACT V A HOSPITAL 18431-06 VISION EYE SC VISION EYE SURGERY CENTER 18445-03 K LEE/LIN CALIFORNIA PACIFIC MED CT 18550-04 DR HU TORRES CAT & LSR CNTRL 18555-04 DR WU - CENTURION CAT & LSR CNTRL 18636-10 CATARACT BONNER GENERAL HOSPITAL

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1644019. Last updated year: 2026. Please use registration number 1644019 when referencing this establishment in official correspondence.
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