Bausch & Lomb Incorporated

FDA Device Registration & Listing · Manchester, MO, US · Registration 1932180

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
1932180
FEI Number
1000119305
Entity Name
Bausch & Lomb Incorporated
City/State/Country
Manchester, MO, US
Establishment Address
499 SOVEREIGN CT., Manchester, MO 63011, 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
Y
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
KYG Device, Irrigation, Ocular Surgery Ophthalmic Class 1 886.4360 2023-07-18
KAG Holder, Speculum, Ent General, Plastic Surgery Class 1 878.1800 1996-11-15
KCP Syringe, Ent Ear, Nose, Throat Class 1 874.5220 1993-01-01
JZD Snare, Ear Ear, Nose, Throat Class 1 874.4420 1993-01-01
EPY Speculum, Ent General, Plastic Surgery Class 1 878.1800 1993-01-01
KAS Knife, Nasal Ear, Nose, Throat Class 1 874.4420 1993-01-01
HQC Unit, Phacofragmentation Ophthalmic Class 2 886.4670 2016-07-14
LRY Punch, Surgical General, Plastic Surgery Class 1 878.4800 1996-10-25
GBX Catheter, Irrigation General, Plastic Surgery Class 1 878.4200 2013-02-11
KAW Punch, Antrum Ear, Nose, Throat Class 1 874.4420 1993-01-01
HXK Holder, Needle; Orthopedic Orthopedic Class 1 888.4540 2025-01-27
JYR Nipper, Malleus Ear, Nose, Throat Class 1 874.4420 1993-01-01
HNC Specula, Ophthalmic Ophthalmic Class 1 886.4350 2004-08-10
FHR Needle, Gastro-Urology General, Plastic Surgery Class 1 878.4800 2025-08-15
MSS Folders And Injectors, Intraocular Lens (Iol) Ophthalmic Class 1 886.4300 2014-03-07
HRR Scissors, Orthopedic, Surgical Orthopedic Class 1 888.4540 2025-08-04
KTE Trocar, Ent Ear, Nose, Throat Class 1 874.4420 1996-12-10
HNN Knife, Ophthalmic Ophthalmic Class 1 886.4350 2005-08-29
BYY Tube, Aspirating, Flexible, Connecting General Hospital Class 2 880.6740 1997-01-08
MXY Cannula, Ophthalmic, Posterior Capsular Polishing, Polyvinyl Acetal Ophthalmic Class 1 886.4350 2025-04-29
KCH Hook, Tracheal Ear, Nose, Throat Class 1 874.4420 1993-01-01
HNS Expressor Ophthalmic Class 1 886.4350 1993-01-01
KBZ Snare, Tonsil Ear, Nose, Throat Class 1 874.4420 1993-01-01
LRW Scissors, General, Surgical General, Plastic Surgery Class 1 878.4800 1996-09-09
HNJ Punch, Corneo-Scleral Ophthalmic Class 1 886.4350 1993-01-12
HNW Dilator, Lachrymal Ophthalmic Class 1 886.4350 1993-01-01
KBM Dissector, Tonsil Ear, Nose, Throat Class 1 874.4420 1993-01-12
KBL Depressor, Metal Tongue, Surgical Ear, Nose, Throat Class 1 874.4420 1993-01-01
HQC Unit, Phacofragmentation Ophthalmic Class 2 886.4670 2012-12-13
KTG Knife, Ent Ear, Nose, Throat Class 1 874.4420 1996-12-09
JYJ Gauge, Measuring Ear, Nose, Throat Class 1 874.4420 1993-01-01
HQC Unit, Phacofragmentation Ophthalmic Class 2 886.4670 2018-04-05
HQF Laser, Ophthalmic Ophthalmic Class 2 886.4390 2018-04-05
HQE Instrument, Vitreous Aspiration And Cutting, Ac-Powered Ophthalmic Class 2 886.4150 2018-04-05
KAN Chisel, Nasal General, Plastic Surgery Class 1 878.4800 1993-01-01
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2020-01-31
HRT Stripper, Surgical Orthopedic Class 1 888.4540 1996-12-10
HOI Spectacle, Magnifying Ophthalmic Class 1 886.5840 2025-08-15
HOE Caliper, Ophthalmic Ophthalmic Class 1 886.4350 1993-01-01
JYQ Loop, Wire Ear, Nose, Throat Class 1 874.4420 2025-04-29
KAA Set, Laryngeal Injection Ear, Nose, Throat Class 1 874.4420 2025-08-04
HNE Snare, Enucleating Ophthalmic Class 1 886.4350 1993-01-01
HNP Introducer, Sphere Ophthalmic Class 1 886.4350 1993-01-01
FXE Speculum, Non-Illuminated General, Plastic Surgery Class 1 878.1800 1993-01-01
KAY Punch, Nasal Ear, Nose, Throat Class 1 874.4420 1993-01-01
KBD Scissors, Nasal Ear, Nose, Throat Class 1 874.4420 1993-01-01
KAC Tube, Laryngectomy Ear, Nose, Throat Class 1 874.4420 1993-01-01
FGY Cannula, Injection General, Plastic Surgery Class 1 878.4200 1993-01-01
EQJ Bur, Ear, Nose And Throat Ear, Nose, Throat Class 1 874.4140 1993-01-01
KYZ Syringe, Irrigating (Non Dental) General Hospital Class 1 880.6960 2024-03-11
HKY Tonometer, Manual Ophthalmic Class 2 886.1930 2013-02-08
KBE Snare, Nasal Ear, Nose, Throat Class 1 874.4420 1993-01-01
LWK Razor, Surgical General, Plastic Surgery Class 1 878.4800 2005-05-26
HNH Ring, Ophthalmic (Flieringa) Ophthalmic Class 1 886.4350 2005-08-29
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
DWS Instruments, Surgical, Cardiovascular Cardiovascular Class 1 870.4500 2013-03-22
HXL Mallet General, Plastic Surgery Class 1 878.4800 2025-08-04
HLN Gauge, Lens, Ophthalmic Ophthalmic Class 1 886.1420 2025-05-13
JBZ Study, Platelet Adhesive Hematology Class 2 864.6650 2025-08-04
KBA Rasp, Nasal Ear, Nose, Throat Class 1 874.4420 1993-01-01
JYW Press, Vein Ear, Nose, Throat Class 1 874.4420 2013-02-01
HNZ Curette, Ophthalmic Ophthalmic Class 1 886.4350 1993-01-01
KAM Cannula, Sinus General, Plastic Surgery Class 1 878.4800 1993-01-01
HNQ Hook, Ophthalmic Ophthalmic Class 1 886.4350 2005-08-29
KAE Forceps, Ent Ear, Nose, Throat Class 1 874.4420 1993-01-01
KAQ Gouge, Nasal, Ent Ear, Nose, Throat Class 1 874.4420 1993-01-12
JYL Hook, Microsurgical Ear Ear, Nose, Throat Class 1 874.4420 1993-01-01
KAP Curette, Nasal Ear, Nose, Throat Class 1 874.4420 1993-01-01
JYY Rasp, Ear Ear, Nose, Throat Class 1 874.4420 1993-01-01
KBQ Knife, Tonsil Ear, Nose, Throat Class 1 874.4420 1993-01-01
HNR Forceps, Ophthalmic Ophthalmic Class 1 886.4350 2004-08-10
KAJ Mobilizer, Ent Ear, Nose, Throat Class 1 874.4420 1996-10-25
JYQ Loop, Wire Ear, Nose, Throat Class 1 874.4420 2025-09-05
HQN Conformer, Ophthalmic Ophthalmic Class 2 886.3130 2006-05-12
GAB Needle, Suturing, Disposable General, Plastic Surgery Class 1 878.4800 1993-01-01
HNF Scissors, Ophthalmic Ophthalmic Class 1 886.4350 2004-08-10
KBH Adenotome Ear, Nose, Throat Class 1 874.4420 1993-01-01
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 1993-01-01
NNR Block, Cutting, Ent, Non-Sterile Ear, Nose, Throat Class 1 874.3540 2025-08-04
JYH Excavator, Ear Ear, Nose, Throat Class 1 874.4420 1993-01-12
GFI Osteotome, Manual General, Plastic Surgery Class 1 878.4800 1993-01-01
HNL Probe, Lachrymal Ophthalmic Class 1 886.4350 1993-01-01
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2008-01-15
LRC Instrument, Ent Manual Surgical Ear, Nose, Throat Class 1 874.4420 2013-02-01
JXS Block, Cutting, Ent, Sterile Ear, Nose, Throat Class 1 874.3540 1993-01-01
GWX Fork, Tuning Neurology Class 1 882.1525 1996-12-10
GDI Dissector, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 1993-01-01
KBN Gag, Mouth Ear, Nose, Throat Class 1 874.4420 1993-01-01
JYF Clamp, Ossicle Holding Ear, Nose, Throat Class 1 874.4420 1996-10-01
GDZ Handle, Scalpel General, Plastic Surgery Class 1 878.4800 2010-12-04
HNB Spoon, Ophthalmic Ophthalmic Class 1 886.4350 1993-01-01
HMQ Marker, Sclera Ophthalmic Class 1 886.4570 1997-01-08
GDH Gouge, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 1996-10-01
HOY Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) Ophthalmic Class 1 886.4750 2005-08-29
GAC Rasp, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 1993-01-01
JYT Pick, Microsurgical Ear Ear, Nose, Throat Class 1 874.4420 1993-01-01
GFJ Mallet, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 1993-01-01
HRB Microscope, Operating, Non-Electric, Ophthalmic General, Plastic Surgery Class 1 878.4700 2014-12-16
JYG Curette, Ear Ear, Nose, Throat Class 1 874.4420 1993-01-01
GEN Forceps, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 1993-01-01
KBS Punch, Adenoid Ear, Nose, Throat Class 1 874.4420 1996-12-23
KCB Tube, Tonsil Suction Ear, Nose, Throat Class 1 874.4420 1993-01-01
MMO Tray, Surgical, Ent Ear, Nose, Throat Class 1 874.4420 2013-02-01
HQE Instrument, Vitreous Aspiration And Cutting, Ac-Powered Ophthalmic Class 2 886.4150 2018-04-05
HKF Mirror, Headband, Ophthalmic Ophthalmic Class 1 886.1500 2025-08-15
HRH Trephine, Manual, Ophthalmic Ophthalmic Class 1 886.4350 2023-05-18
HXB Probe Orthopedic Class 1 888.4540 2013-02-01
KCJ Applicator, Ent Ear, Nose, Throat Class 1 874.5220 1993-01-01
FZX Guide, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 1996-12-09
LXZ Guard, Instrument General, Plastic Surgery Class 1 878.4800 2025-08-15
HOD Clamp, Eyelid, Ophthalmic Ophthalmic Class 1 886.4350 1989-02-22
KAL Retractor, Ent Ear, Nose, Throat Class 1 874.4420 1993-01-01
CAT Cannula, Nasal, Oxygen Anesthesiology Class 1 868.5340 1993-01-01
EMF Knife, Surgical General, Plastic Surgery Class 1 878.4800 1993-01-01
GAD Retractor General, Plastic Surgery Class 1 878.4800 1993-01-12
JYA Scissors, Wire Cutting, Ent, Sterile Ear, Nose, Throat Class 1 874.3540 1993-01-01
HOB Clamp, Muscle, Ophthalmic Ophthalmic Class 1 886.4350 2004-08-10
KTF Punch, Ent Ear, Nose, Throat Class 1 874.4420 2013-02-01
GAZ Tubing, Noninvasive General Hospital Class 2 880.6740 2006-05-12
HMZ Trabeculotome Ophthalmic Class 1 886.4350 1993-01-01

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
1920664 Bausch & Lomb Incorporated Saint Louis, MO, US
1032500 Bausch & Lomb Incorporated GREENVILLE, SC, US
3007583964 TOTAL TITANIUM, INC. Red Bud, IL, US
1281950 Bausch & Lomb Incorporated WILMINGTON, MA, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K834189 Imm Enterprises , Ltd. JAKOBI SURG. INSTRUMENTS #7 44/47 1984-03-06
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-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.
Z-2109-2025 Alcon Research LLC 2
Brand Name: Alcon Laboratories, Inc. Product Name: Constellation Vision System Combined Procedure Pak Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' Software Version: N/A Product Description: Surgical procedure pack to interface with Alcon Constellation Surgical console. Component: N/A

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1932180. Last updated year: 2026. Please use registration number 1932180 when referencing this establishment in official correspondence.
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