Alcon Research, LLC

FDA Device Registration & Listing · Lake Forest, CA, US · Registration 3010208880

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
3010208880
FEI Number
3010208880
Entity Name
Alcon Research, LLC
City/State/Country
Lake Forest, CA, US
Establishment Address
20511 Lake Forest Dr, Lake Forest, CA 92630, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
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
K120912
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
HMX Cannula, Ophthalmic Ophthalmic Class 1 886.4350 2012-04-19
HQE Instrument, Vitreous Aspiration And Cutting, Ac-Powered Ophthalmic Class 2 886.4150 2012-04-19
HQB Photocoagulator And Accessories Ophthalmic Class 2 886.4690 2012-04-19
NGY Cannula, Trocar, Ophthalmic Ophthalmic Class 1 886.4350 2012-04-19
HQC Unit, Phacofragmentation Ophthalmic Class 2 886.4670 2024-04-03
ORZ Eyelid Thermal Pulsation System Ophthalmic Class 2 886.5200 2020-09-18
HQE Instrument, Vitreous Aspiration And Cutting, Ac-Powered Ophthalmic Class 2 886.4150 2020-01-14
MLZ Vitrectomy, Instrument Cutter Ophthalmic Class 2 886.4150 2020-01-14
HMF Stand, Instrument, Ac-Powered, Ophthalmic Ophthalmic Class 1 886.1860 2024-02-05
GBX Catheter, Irrigation General, Plastic Surgery Class 1 878.4200 2012-04-19
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
HRM Microscope, Operating & Accessories, Ac-Powered, Ophthalmic General, Plastic Surgery Class 1 878.4700 1994-02-03
HQC Unit, Phacofragmentation Ophthalmic Class 2 886.4670 2019-11-13
FWJ Camera, Cine, Microsurgical, Without Audio General, Plastic Surgery Class 1 878.4160 2016-08-29
NGY Cannula, Trocar, Ophthalmic Ophthalmic Class 1 886.4350 2009-04-16
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
HNO Keratome, Ac-Powered Ophthalmic Class 1 886.4370 2025-09-25
HQC Unit, Phacofragmentation Ophthalmic Class 2 886.4670 2025-09-25
OOE Ophthalmic Femtosecond Laser Ophthalmic Class 2 886.4390 2025-09-25
KYB Lens, Guide, Intraocular Ophthalmic Class 1 886.4300 2013-11-15
HQC Unit, Phacofragmentation Ophthalmic Class 2 886.4670 2013-11-15
MLZ Vitrectomy, Instrument Cutter Ophthalmic Class 2 886.4150 2013-11-15
HQR Apparatus, Cautery, Radiofrequency, Ac-Powered Ophthalmic Class 2 886.4100 2013-11-15

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-0099-2024 Alcon Research, LLC 2
Constellation Vision System, REF: 8065751150
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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010208880. Last updated year: 2026. Please use registration number 3010208880 when referencing this establishment in official correspondence.
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