Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1920664

FEI Number

1920664

Entity Name

Bausch & Lomb Incorporated

City/State/Country

Saint Louis, MO, US

Establishment Address

3365 TREE CT. INDUSTRIAL BLVD., Saint Louis, MO 63122, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Bausch & Lomb Incorporated (Owner Number: 9913003)

Owner / Operator Contact Address

400 Somerset Corporate Blvd., --, Bridgewater, NJ 08807, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

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
OOE	Ophthalmic Femtosecond Laser	Ophthalmic	Class 2	886.4390	2015-06-09
HQC	Unit, Phacofragmentation	Ophthalmic	Class 2	886.4670	2008-01-16
HQE	Instrument, Vitreous Aspiration And Cutting, Ac-Powered	Ophthalmic	Class 2	886.4150	2008-01-16
HQC	Unit, Phacofragmentation	Ophthalmic	Class 2	886.4670	2016-07-25
HQC	Unit, Phacofragmentation	Ophthalmic	Class 2	886.4670	2008-01-16
HQE	Instrument, Vitreous Aspiration And Cutting, Ac-Powered	Ophthalmic	Class 2	886.4150	2008-01-16
KAE	Forceps, Ent	Ear, Nose, Throat	Class 1	874.4420	1993-01-01
LYX	Media, Corneal Storage	Unknown	Class U	N/A	2016-07-27
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2025-09-24
HBI	Illuminator, Fiberoptic, Surgical Field	General, Plastic Surgery	Class 2	878.4580	2008-01-24
GXI	Probe, Radiofrequency Lesion	Neurology	Class 2	882.4725	2009-03-26
HQC	Unit, Phacofragmentation	Ophthalmic	Class 2	886.4670	2016-08-31
HNO	Keratome, Ac-Powered	Ophthalmic	Class 1	886.4370	2015-06-09
MXK	Device, Analysis, Anterior Segment	Ophthalmic	Class 2	886.1850	2006-02-13
HBI	Illuminator, Fiberoptic, Surgical Field	General, Plastic Surgery	Class 2	878.4580	2008-01-24
HQF	Laser, Ophthalmic	Ophthalmic	Class 2	886.4390	2024-10-14
HQC	Unit, Phacofragmentation	Ophthalmic	Class 2	886.4670	2024-10-14
HQE	Instrument, Vitreous Aspiration And Cutting, Ac-Powered	Ophthalmic	Class 2	886.4150	2024-10-14
GDM	Needle, Aspiration And Injection, Reusable	General, Plastic Surgery	Class 1	878.4800	1996-11-05
HQC	Unit, Phacofragmentation	Ophthalmic	Class 2	886.4670	2016-09-20
NCF	Aberrometer, Ophthalmic	Ophthalmic	Class 1	886.1760	2002-04-12
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2005-08-29
HQC	Unit, Phacofragmentation	Ophthalmic	Class 2	886.4670	2023-06-19
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	1993-01-01
HQC	Unit, Phacofragmentation	Ophthalmic	Class 2	886.4670	2010-11-17
HQE	Instrument, Vitreous Aspiration And Cutting, Ac-Powered	Ophthalmic	Class 2	886.4150	2010-11-17
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2017-05-08
HQE	Instrument, Vitreous Aspiration And Cutting, Ac-Powered	Ophthalmic	Class 2	886.4150	2023-10-31
HQC	Unit, Phacofragmentation	Ophthalmic	Class 2	886.4670	2023-06-19
HQF	Laser, Ophthalmic	Ophthalmic	Class 2	886.4390	2012-12-13
NGY	Cannula, Trocar, Ophthalmic	Ophthalmic	Class 1	886.4350	2005-08-29
HQC	Unit, Phacofragmentation	Ophthalmic	Class 2	886.4670	2023-07-18
MOE	Collagen Corneal Shield	Ophthalmic	Class 1	886.4750	2006-02-13
HQE	Instrument, Vitreous Aspiration And Cutting, Ac-Powered	Ophthalmic	Class 2	886.4150	2012-01-24
HQC	Unit, Phacofragmentation	Ophthalmic	Class 2	886.4670	2012-01-24
HQF	Laser, Ophthalmic	Ophthalmic	Class 2	886.4390	2026-04-08
HQE	Instrument, Vitreous Aspiration And Cutting, Ac-Powered	Ophthalmic	Class 2	886.4150	2026-04-08
HQC	Unit, Phacofragmentation	Ophthalmic	Class 2	886.4670	2026-04-08
HQC	Unit, Phacofragmentation	Ophthalmic	Class 2	886.4670	2020-01-31
HQE	Instrument, Vitreous Aspiration And Cutting, Ac-Powered	Ophthalmic	Class 2	886.4150	2020-01-31
HQC	Unit, Phacofragmentation	Ophthalmic	Class 2	886.4670	2020-01-31
HQC	Unit, Phacofragmentation	Ophthalmic	Class 2	886.4670	2016-09-23
MRH	Pump, Infusion, Ophthalmic	General Hospital	Class 2	880.5725	2024-08-12
MPA	Endoilluminator	Gastroenterology, Urology	Class 2	876.1500	2008-01-24
KYG	Device, Irrigation, Ocular Surgery	Ophthalmic	Class 1	886.4360	2023-07-18

Official Correspondent

Margaret Wood

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Bausch & Lomb Incorporated

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
1119279	Bausch & Lomb Incorporated	CLEARWATER, FL, US
1032500	Bausch & Lomb Incorporated	GREENVILLE, SC, US
3007583964	TOTAL TITANIUM, INC.	Red Bud, IL, US
1281950	Bausch & Lomb Incorporated	WILMINGTON, MA, US
1315522	Bausch & Lomb Incorporated	Lancaster, NY, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K170322	Abbott Medical Optics, Inc.	Catalys Precision Laser System	2017-05-19
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-1515-2015	Abbott Medical Optics, Inc.	2	OptiMedica Catalys Precision Laser System; Model No(s). Catalys-U (US), and Catalys-I (Outside US). Product Usage: Indicated for use in patients undergoing cataract surgery for removal of crystalline lens.
Z-1670-2013	Abbott Medical Optics, Inc.	2	Sovereign Compact Phacoemulsification System, v 5.3, Part Number: CMP680300. The system is used for cataract surgery.
Z-0099-2024	Alcon Research, LLC	2	Constellation Vision System, REF: 8065751150
Z-0305-2026	Alcon Research LLC	2	Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' 8065750918 PAK,I/A LINE,NGVS 8065750957 ASSY,SHIP,CONSTELLATION VFC 8065750972 ENDOILLUMATOR,RFID,23G 8065751014 CONST AUTO GAS FILL PAK 8065751014 CONST AUTO GAS FILL PAK 8065751441 ENDOILLUMINATOR,RFID,25G 8065751577 CHANDELIER,25GA,W/RFID Software Version: N/A Product Description: These products are standalone accessory devices meant for vitrectomy surgical procedures. They interface with a corresponding Alcon surgical console. Component: N/A
Z-1794-2020	Alcon Research LLC	2	Alcon Constellation Vision System 20 GA TOTALPLUS Combined Procedure Pak, Product #8065751079, Sterile. The firm name on the label is Alcon Laboratories, Inc., Fort Worth, TX.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1920664. Last updated year: 2026. Please use registration number 1920664 when referencing this establishment in official correspondence.