Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013497605

FEI Number

3013497605

Entity Name

Alcon Research, LLC

City/State/Country

Sinking Spring, PA, US

Establishment Address

700 Old Fritztown Rd, Sinking Spring, PA 19608, 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

Expiration Date (Year)

2026

510(k) Number

K233902

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
HQC	Unit, Phacofragmentation	Ophthalmic	Class 2	886.4670	2024-04-03

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
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
1119421	Alcon Research, LLC	HUNTINGTON, WV, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K191650	Alcon Research, LLC	LEGION System	2019-11-01
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
K121721	Abbott Medical Optics, Inc.	LAMINAR FLOW PHACO TIPS AND IRRIGATION SLEEVE (21G, REUSABLE)	2012-10-15

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

Similar Registrations

Registration Number	Establishment Name	Location
3005012805	MIDWEST STERILIZATION CORP.	LAREDO, TX, US
2028159	Alcon Research, LLC	IRVINE, CA, US
1650907	Isomedix Operations Inc.	GRAND PRAIRIE, TX, US
3003365815	Bausch+Lomb Netherlands B.V. Amsterdam Logistics Centre	SCHIPOL RIJK Noord-Holland, NL
3007867838	Sanmina	SAN JOSE, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013497605. Last updated year: 2026. Please use registration number 3013497605 when referencing this establishment in official correspondence.