Bausch & Lomb Incorporated

FDA Device Registration & Listing · Rochester, NY, US · Registration 1313525

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
1313525
FEI Number
1317628
Entity Name
Bausch & Lomb Incorporated
City/State/Country
Rochester, NY, US
Establishment Address
1400 North Goodman Street, Rochester, NY 14609, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198
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
K143632
PMA Number
N/A

All Registered Proprietary Names

CX9626 25GA SYST -6/box

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GEN Forceps, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 1993-01-01
KYB Lens, Guide, Intraocular Ophthalmic Class 1 886.4300 2010-11-04
HXZ Cutter, Wire Orthopedic Class 1 888.4540 1996-10-25
HQD Lens, Contact (Other Material) - Daily Ophthalmic Class 2 886.5916 2023-01-19
HQL Intraocular Lens Ophthalmic Class 3 886.3600 2008-01-17
CAF Nebulizer (Direct Patient Interface) Anesthesiology Class 2 868.5630 2017-05-08
HMQ Marker, Sclera Ophthalmic Class 1 886.4570 1997-01-08
GBX Catheter, Irrigation General, Plastic Surgery Class 1 878.4200 2013-02-11
HKF Mirror, Headband, Ophthalmic Ophthalmic Class 1 886.1500 2025-08-15
MWL Lens, Contact (Rigid Gas Permeable), Extended Wear Ophthalmic Class 3 886.5916 2005-08-01
NUU Lens, Contact, Orthokeratology, Overnight Ophthalmic Class 3 886.5916 2005-08-01
HQB Photocoagulator And Accessories Ophthalmic Class 2 886.4690 2024-04-05
HNX Depressor, Orbital Ophthalmic Class 1 886.4350 1996-10-01
MSS Folders And Injectors, Intraocular Lens (Iol) Ophthalmic Class 1 886.4300 2012-12-13
HQD Lens, Contact (Other Material) - Daily Ophthalmic Class 2 886.5916 2008-01-09
MRC Products, Contact Lens Care, Rigid Gas Permeable Ophthalmic Class 2 886.5918 2020-06-20
MUU System, Suction, Lipoplasty General, Plastic Surgery Class 2 878.5040 2016-01-11
HQL Intraocular Lens Ophthalmic Class 3 886.3600 2008-01-17
IMI Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat Physical Medicine Class 2 890.5300 2016-01-11
ISA Massager, Therapeutic, Electric Physical Medicine Class 1 890.5660 2016-01-11
HOY Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) Ophthalmic Class 1 886.4750 2005-08-29
QPB System, Suction, Lipoplasty For Removal General, Plastic Surgery Class 2 878.5040 2016-01-11
LPN Accessories, Soft Lens Products Ophthalmic Class 2 886.5928 2008-01-10
HNJ Punch, Corneo-Scleral Ophthalmic Class 1 886.4350 1993-01-12
OJK Eye Tray Ophthalmic Class 2 886.4790 2011-07-27
IME Pack, Hot Or Cold, Reusable Physical Medicine Class 1 890.5700 2022-09-12
LPL Lenses, Soft Contact, Daily Wear Ophthalmic Class 2 886.5925 2008-01-02
LPM Lenses, Soft Contact, Extended Wear Ophthalmic Class 3 886.5925 2008-01-02
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2020-01-31
LWL Fluid, Intraocular Ophthalmic Class 3 886.4275 2008-01-18
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2025-09-24
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
CAT Cannula, Nasal, Oxygen Anesthesiology Class 1 868.5340 1993-01-01
LPN Accessories, Soft Lens Products Ophthalmic Class 2 886.5928 2008-01-10
MOE Collagen Corneal Shield Ophthalmic Class 1 886.4750 2006-02-13
JYA Scissors, Wire Cutting, Ent, Sterile Ear, Nose, Throat Class 1 874.3540 1993-01-01
GFI Osteotome, Manual General, Plastic Surgery Class 1 878.4800 1993-01-01
HQE Instrument, Vitreous Aspiration And Cutting, Ac-Powered Ophthalmic Class 2 886.4150 2023-10-31
HLN Gauge, Lens, Ophthalmic Ophthalmic Class 1 886.1420 2025-05-13
OHV Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption General, Plastic Surgery Class 2 878.4590 2016-01-11
KAJ Mobilizer, Ent Ear, Nose, Throat Class 1 874.4420 1996-10-25
HNF Scissors, Ophthalmic Ophthalmic Class 1 886.4350 2004-08-10
MSS Folders And Injectors, Intraocular Lens (Iol) Ophthalmic Class 1 886.4300 2008-01-07
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2016-01-11
MSS Folders And Injectors, Intraocular Lens (Iol) Ophthalmic Class 1 886.4300 2010-11-04
KCH Hook, Tracheal Ear, Nose, Throat Class 1 874.4420 1993-01-01
JYQ Loop, Wire Ear, Nose, Throat Class 1 874.4420 2025-04-29
HQD Lens, Contact (Other Material) - Daily Ophthalmic Class 2 886.5916 2008-01-09
MPA Endoilluminator Gastroenterology, Urology Class 2 876.1500 2024-04-05
HRB Microscope, Operating, Non-Electric, Ophthalmic General, Plastic Surgery Class 1 878.4700 2014-12-16
KAY Punch, Nasal Ear, Nose, Throat Class 1 874.4420 1993-01-01
HNZ Curette, Ophthalmic Ophthalmic Class 1 886.4350 1993-01-01
KAW Punch, Antrum Ear, Nose, Throat Class 1 874.4420 1993-01-01
KBM Dissector, Tonsil Ear, Nose, Throat Class 1 874.4420 1993-01-12
KBZ Snare, Tonsil Ear, Nose, Throat Class 1 874.4420 1993-01-01
HQB Photocoagulator And Accessories Ophthalmic Class 2 886.4690 2024-04-05
HQF Laser, Ophthalmic Ophthalmic Class 2 886.4390 2024-04-05
MPA Endoilluminator Gastroenterology, Urology Class 2 876.1500 2024-04-05
ONG Powered Laser Surgical Instrument With MicrobeamFractional Output General, Plastic Surgery Class 2 878.4810 2016-01-11
LYX Media, Corneal Storage Unknown Class U N/A 2016-07-27
HND Spatula, Ophthalmic Ophthalmic Class 1 886.4350 1993-01-01
HOI Spectacle, Magnifying Ophthalmic Class 1 886.5840 2025-08-15
HRR Scissors, Orthopedic, Surgical Orthopedic Class 1 888.4540 2025-08-04
JBZ Study, Platelet Adhesive Hematology Class 2 864.6650 2025-08-04
LYX Media, Corneal Storage Unknown Class U N/A 2017-01-04
LWK Razor, Surgical General, Plastic Surgery Class 1 878.4800 2005-05-26
MSS Folders And Injectors, Intraocular Lens (Iol) Ophthalmic Class 1 886.4300 2020-08-06
KBD Scissors, Nasal Ear, Nose, Throat Class 1 874.4420 1993-01-01
LPN Accessories, Soft Lens Products Ophthalmic Class 2 886.5928 2008-01-10
KTG Knife, Ent Ear, Nose, Throat Class 1 874.4420 1996-12-09
HNN Knife, Ophthalmic Ophthalmic Class 1 886.4350 2005-08-29
MSS Folders And Injectors, Intraocular Lens (Iol) Ophthalmic Class 1 886.4300 2014-03-07
HRH Trephine, Manual, Ophthalmic Ophthalmic Class 1 886.4350 1993-01-01
LPN Accessories, Soft Lens Products Ophthalmic Class 2 886.5928 2021-07-23
KBN Gag, Mouth Ear, Nose, Throat Class 1 874.4420 1993-01-01
KBJ Curette, Adenoid Ear, Nose, Throat Class 1 874.4420 1993-01-01
KCP Syringe, Ent Ear, Nose, Throat Class 1 874.5220 1993-01-01
MRC Products, Contact Lens Care, Rigid Gas Permeable Ophthalmic Class 2 886.5918 2020-06-25
HQE Instrument, Vitreous Aspiration And Cutting, Ac-Powered Ophthalmic Class 2 886.4150 2024-04-05
HQF Laser, Ophthalmic Ophthalmic Class 2 886.4390 2024-04-05
LPL Lenses, Soft Contact, Daily Wear Ophthalmic Class 2 886.5925 2010-08-12
FXE Speculum, Non-Illuminated General, Plastic Surgery Class 1 878.1800 1993-01-01
NPL Barrier, Animal Source, Intraoral Dental Class 2 872.3930 2016-09-19
HNM Needle, Ophthalmic Suturing Ophthalmic Class 1 886.4350 1993-01-01
KCJ Applicator, Ent Ear, Nose, Throat Class 1 874.5220 1993-01-01
HNA Spud, Ophthalmic Ophthalmic Class 1 886.4350 1993-01-01
FZX Guide, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 1996-12-09
KCB Tube, Tonsil Suction 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
LPN Accessories, Soft Lens Products Ophthalmic Class 2 886.5928 2008-01-10
HQD Lens, Contact (Other Material) - Daily Ophthalmic Class 2 886.5916 2008-01-09
JXT Crimper, Wire, Ent, Sterile Ear, Nose, Throat Class 1 874.3540 1993-01-01
GEA Cannula, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 1996-11-05
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2016-01-11
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2016-01-11
KAN Chisel, Nasal General, Plastic Surgery Class 1 878.4800 1993-01-01
HPX Lens, Contact (Polymethylmethacrylate) Unknown Class U N/A 2008-01-14
LZP Aid, Surgical, Viscoelastic Ophthalmic Class 3 886.4275 2023-04-07
MXY Cannula, Ophthalmic, Posterior Capsular Polishing, Polyvinyl Acetal Ophthalmic Class 1 886.4350 2025-04-29
LPL Lenses, Soft Contact, Daily Wear Ophthalmic Class 2 886.5925 2008-01-08
HNP Introducer, Sphere Ophthalmic Class 1 886.4350 1993-01-01
HQD Lens, Contact (Other Material) - Daily Ophthalmic Class 2 886.5916 2008-01-09
MRC Products, Contact Lens Care, Rigid Gas Permeable Ophthalmic Class 2 886.5918 2020-10-19
JXS Block, Cutting, Ent, Sterile Ear, Nose, Throat Class 1 874.3540 1993-01-01
FHR Needle, Gastro-Urology General, Plastic Surgery Class 1 878.4800 2025-08-15
HBI Illuminator, Fiberoptic, Surgical Field General, Plastic Surgery Class 2 878.4580 2008-01-24
GAC Rasp, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 1993-01-01
NPL Barrier, Animal Source, Intraoral Dental Class 2 872.3930 2016-05-12
HQD Lens, Contact (Other Material) - Daily Ophthalmic Class 2 886.5916 2008-01-09
FTY Tape, Measuring, Rulers And Calipers General, Plastic Surgery Class 1 878.4800 1993-01-01
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2016-01-11
HNQ Hook, Ophthalmic Ophthalmic Class 1 886.4350 2005-08-29
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
NCF Aberrometer, Ophthalmic Ophthalmic Class 1 886.1760 2002-04-12
KBS Punch, Adenoid Ear, Nose, Throat Class 1 874.4420 1996-12-23
MSS Folders And Injectors, Intraocular Lens (Iol) Ophthalmic Class 1 886.4300 2017-05-31
JOL Catheter And Tip, Suction General Hospital Class 2 880.6740 1993-01-01
DWS Instruments, Surgical, Cardiovascular Cardiovascular Class 1 870.4500 2013-03-22
MRC Products, Contact Lens Care, Rigid Gas Permeable Ophthalmic Class 2 886.5918 2008-01-10
LXZ Guard, Instrument General, Plastic Surgery Class 1 878.4800 2025-08-15
MMO Tray, Surgical, Ent Ear, Nose, Throat Class 1 874.4420 2013-02-01
JYT Pick, Microsurgical Ear Ear, Nose, Throat Class 1 874.4420 1993-01-01
HQD Lens, Contact (Other Material) - Daily Ophthalmic Class 2 886.5916 2025-12-09
JYY Rasp, Ear Ear, Nose, Throat Class 1 874.4420 1993-01-01
MRC Products, Contact Lens Care, Rigid Gas Permeable Ophthalmic Class 2 886.5918 2020-06-25
MVN Lens, Contact, (Disposable) Ophthalmic Class 2 886.5925 2008-10-21
LYL Accessories, Solution, Ultrasonic Cleaners For Lenses Ophthalmic Class 2 886.5928 2010-05-03
MFK Lens, Multifocal Intraocular Ophthalmic Class 3 886.3600 2024-10-11
MJP Lens, Intraocular, Toric Optics Ophthalmic Class 3 886.3600 2024-10-11
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
FZS Curette, Surgical, General Use General, Plastic Surgery Class 1 878.4800 1993-01-01
KYB Lens, Guide, Intraocular Ophthalmic Class 1 886.4300 2014-12-08
LPM Lenses, Soft Contact, Extended Wear Ophthalmic Class 3 886.5925 2007-12-17
LPL Lenses, Soft Contact, Daily Wear Ophthalmic Class 2 886.5925 2014-04-02
MVN Lens, Contact, (Disposable) Ophthalmic Class 2 886.5925 2014-04-02
HQE Instrument, Vitreous Aspiration And Cutting, Ac-Powered Ophthalmic Class 2 886.4150 2026-06-16
LYX Media, Corneal Storage Unknown Class U N/A 2015-05-14
JYJ Gauge, Measuring Ear, Nose, Throat Class 1 874.4420 1993-01-01
HXB Probe Orthopedic Class 1 888.4540 2013-02-01
HQL Intraocular Lens Ophthalmic Class 3 886.3600 2008-01-17
HMR Marker, Ocular Ophthalmic Class 1 886.4570 1996-11-05
EQJ Bur, Ear, Nose And Throat Ear, Nose, Throat Class 1 874.4140 1993-01-01
LPN Accessories, Soft Lens Products Ophthalmic Class 2 886.5928 2022-02-15
MRC Products, Contact Lens Care, Rigid Gas Permeable Ophthalmic Class 2 886.5918 2022-02-15
LPL Lenses, Soft Contact, Daily Wear Ophthalmic Class 2 886.5925 2021-09-10
MVN Lens, Contact, (Disposable) Ophthalmic Class 2 886.5925 2021-09-10
GDM Needle, Aspiration And Injection, Reusable General, Plastic Surgery Class 1 878.4800 1996-11-05
KBL Depressor, Metal Tongue, Surgical Ear, Nose, Throat Class 1 874.4420 1993-01-01
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2016-01-11
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2016-01-11
HQC Unit, Phacofragmentation Ophthalmic Class 2 886.4670 2023-07-18
GAD Retractor General, Plastic Surgery Class 1 878.4800 1993-01-12
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
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
HQF Laser, Ophthalmic Ophthalmic Class 2 886.4390 2020-01-31
JYO Knife, Ear Ear, Nose, Throat Class 1 874.4420 1993-01-01
LYX Media, Corneal Storage Unknown Class U N/A 2022-01-10
HOF Burr, Corneal, Manual Ophthalmic Class 1 886.4350 2005-08-29
HNY Cystotome Ophthalmic Class 1 886.4350 2005-08-29
BYX Tubing, Pressure And Accessories Anesthesiology Class 1 868.5860 2019-05-20
GWX Fork, Tuning Neurology Class 1 882.1525 1996-12-10
LRX Case, Contact Lens Ophthalmic Class 2 886.5928 2012-09-21
FFO Retractor, Self-Retaining Gastroenterology, Urology Class 1 876.4730 2013-02-01
HQF Laser, Ophthalmic Ophthalmic Class 2 886.4390 2012-12-13
NNR Block, Cutting, Ent, Non-Sterile Ear, Nose, Throat Class 1 874.3540 2025-08-04
MRH Pump, Infusion, Ophthalmic General Hospital Class 2 880.5725 2024-08-12
LRW Scissors, General, Surgical General, Plastic Surgery Class 1 878.4800 1996-09-09
GAB Needle, Suturing, Disposable General, Plastic Surgery Class 1 878.4800 1993-01-01
HNG Rongeur, Lachrymal Sac Ophthalmic Class 1 886.4350 1993-01-01
KAI Mirror, Ent Ear, Nose, Throat Class 1 874.4420 1993-01-01
LPN Accessories, Soft Lens Products Ophthalmic Class 2 886.5928 2008-01-10
KBB Rongeur, Nasal Ear, Nose, Throat Class 1 874.4420 1993-01-01
QPB System, Suction, Lipoplasty For Removal General, Plastic Surgery Class 2 878.5040 2016-01-11
LPL Lenses, Soft Contact, Daily Wear Ophthalmic Class 2 886.5925 2025-01-31
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2021-07-30
JYG Curette, Ear Ear, Nose, Throat Class 1 874.4420 1993-01-01
LPN Accessories, Soft Lens Products Ophthalmic Class 2 886.5928 2017-01-17
HQL Intraocular Lens Ophthalmic Class 3 886.3600 2008-09-22
KYZ Syringe, Irrigating (Non Dental) General Hospital Class 1 880.6960 2024-03-11
GEG Elevator, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 1993-01-01
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2008-01-15
LPN Accessories, Soft Lens Products Ophthalmic Class 2 886.5928 2008-05-27
HMX Cannula, Ophthalmic Ophthalmic Class 1 886.4350 2005-08-29
KAK Probe, Ent Ear, Nose, Throat Class 1 874.4420 1993-01-01
NPL Barrier, Animal Source, Intraoral Dental Class 2 872.3930 2017-03-07
MSS Folders And Injectors, Intraocular Lens (Iol) Ophthalmic Class 1 886.4300 2016-12-20
KAM Cannula, Sinus General, Plastic Surgery Class 1 878.4800 1993-01-01
HKY Tonometer, Manual Ophthalmic Class 2 886.1930 2013-02-08
KYG Device, Irrigation, Ocular Surgery Ophthalmic Class 1 886.4360 2023-07-18
LPN Accessories, Soft Lens Products Ophthalmic Class 2 886.5928 2008-05-12
MRC Products, Contact Lens Care, Rigid Gas Permeable Ophthalmic Class 2 886.5918 2008-01-10
FZO Chisel, Surgical, Manual General, Plastic Surgery Class 1 878.4800 1993-01-01
JYS Perforator, Ear-Lobe Ear, Nose, Throat Class 1 874.4420 2025-08-04
HNH Ring, Ophthalmic (Flieringa) Ophthalmic Class 1 886.4350 2005-08-29
HQL Intraocular Lens Ophthalmic Class 3 886.3600 2017-05-31
MRC Products, Contact Lens Care, Rigid Gas Permeable Ophthalmic Class 2 886.5918 2023-09-05
LPN Accessories, Soft Lens Products Ophthalmic Class 2 886.5928 2023-09-05
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
JZF Tube, Ear Suction Ear, Nose, Throat Class 1 874.4420 1993-01-01
KBH Adenotome Ear, Nose, Throat Class 1 874.4420 1993-01-01
LPN Accessories, Soft Lens Products Ophthalmic Class 2 886.5928 2008-01-10
JZB Scissors, Ear Ear, Nose, Throat Class 1 874.4420 1993-01-01
HNL Probe, Lachrymal Ophthalmic Class 1 886.4350 1993-01-01
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2020-02-07
FHQ Holder, Needle, Gastroenterologic Gastroenterology, Urology Class 1 876.4730 1993-01-12
LPL Lenses, Soft Contact, Daily Wear Ophthalmic Class 2 886.5925 2014-05-19
MVN Lens, Contact, (Disposable) Ophthalmic Class 2 886.5925 2014-05-19
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 1993-01-01
KBR Needle, Tonsil Suturing Ear, Nose, Throat Class 1 874.4420 1993-01-12
MJP Lens, Intraocular, Toric Optics Ophthalmic Class 3 886.3600 2008-03-12
NAA Lens, Intraocular, Accommodative Ophthalmic Class 3 886.3600 2008-03-12
NGY Cannula, Trocar, Ophthalmic Ophthalmic Class 1 886.4350 2005-08-29
JYL Hook, Microsurgical Ear Ear, Nose, Throat Class 1 874.4420 1993-01-01
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2016-01-11
HNE Snare, Enucleating Ophthalmic Class 1 886.4350 1993-01-01
FGY Cannula, Injection General, Plastic Surgery Class 1 878.4200 1993-01-01
JXX Forceps, Wire Closure, Ent, Sterile Ear, Nose, Throat Class 1 874.3540 1993-01-01
NPM Bone Grafting Material, Animal Source Dental Class 2 872.3930 2018-01-10
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2016-06-21
HOE Caliper, Ophthalmic Ophthalmic Class 1 886.4350 1993-01-01
KBE Snare, Nasal Ear, Nose, Throat Class 1 874.4420 1993-01-01
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2016-01-11
NGY Cannula, Trocar, Ophthalmic Ophthalmic Class 1 886.4350 2025-07-10
MVN Lens, Contact, (Disposable) Ophthalmic Class 2 886.5925 2006-05-12
HQC Unit, Phacofragmentation Ophthalmic Class 2 886.4670 2023-06-19
KAL Retractor, Ent Ear, Nose, Throat Class 1 874.4420 1993-01-01
MJP Lens, Intraocular, Toric Optics Ophthalmic Class 3 886.3600 2008-01-17
HQL Intraocular Lens Ophthalmic Class 3 886.3600 2008-01-17
JYR Nipper, Malleus Ear, Nose, Throat Class 1 874.4420 1993-01-01
GDI Dissector, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 1993-01-01
MSS Folders And Injectors, Intraocular Lens (Iol) Ophthalmic Class 1 886.4300 2014-03-07
MPA Endoilluminator Gastroenterology, Urology Class 2 876.1500 2008-01-15
HXL Mallet General, Plastic Surgery Class 1 878.4800 2025-08-04
MVN Lens, Contact, (Disposable) Ophthalmic Class 2 886.5925 2019-05-03
LPL Lenses, Soft Contact, Daily Wear Ophthalmic Class 2 886.5925 2019-05-03
HNC Specula, Ophthalmic Ophthalmic Class 1 886.4350 2004-08-10
HOB Clamp, Muscle, Ophthalmic Ophthalmic Class 1 886.4350 2004-08-10
EMF Knife, Surgical General, Plastic Surgery Class 1 878.4800 1993-01-01
KBA Rasp, Nasal Ear, Nose, Throat Class 1 874.4420 1993-01-01
HQC Unit, Phacofragmentation Ophthalmic Class 2 886.4670 2016-07-14
HQF Laser, Ophthalmic Ophthalmic Class 2 886.4390 2017-04-18
HQE Instrument, Vitreous Aspiration And Cutting, Ac-Powered Ophthalmic Class 2 886.4150 2017-04-18
HQC Unit, Phacofragmentation Ophthalmic Class 2 886.4670 2017-04-18
MSS Folders And Injectors, Intraocular Lens (Iol) Ophthalmic Class 1 886.4300 2016-12-20
HQC Unit, Phacofragmentation Ophthalmic Class 2 886.4670 2016-07-25
MRJ Ring, Endocapsular Unknown Class 3 N/A 2018-03-13
GDG Hook, Surgical, General & Plastic Surgery 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
HQD Lens, Contact (Other Material) - Daily Ophthalmic Class 2 886.5916 2008-01-09
MUW Lens, Contact (Orthokeratology) Ophthalmic Class 2 886.5916 2008-01-09
LZP Aid, Surgical, Viscoelastic Ophthalmic Class 3 886.4275 2008-01-17
GDT Staple, Removable (Skin) General, Plastic Surgery Class 1 878.4760 1993-01-12
GDH Gouge, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 1996-10-01
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
KBQ Knife, Tonsil Ear, Nose, Throat Class 1 874.4420 1993-01-01
MSS Folders And Injectors, Intraocular Lens (Iol) Ophthalmic Class 1 886.4300 2025-03-13
LYL Accessories, Solution, Ultrasonic Cleaners For Lenses Ophthalmic Class 2 886.5928 2008-01-10
LPN Accessories, Soft Lens Products Ophthalmic Class 2 886.5928 2023-12-14
HQN Conformer, Ophthalmic Ophthalmic Class 2 886.3130 2006-05-12
LRY Punch, Surgical General, Plastic Surgery Class 1 878.4800 1996-10-25
ONG Powered Laser Surgical Instrument With MicrobeamFractional Output General, Plastic Surgery Class 2 878.4810 2016-01-11
HNS Expressor Ophthalmic Class 1 886.4350 1993-01-01
MRH Pump, Infusion, Ophthalmic General Hospital Class 2 880.5725 2018-05-09
LPL Lenses, Soft Contact, Daily Wear Ophthalmic Class 2 886.5925 2016-08-26
MVN Lens, Contact, (Disposable) Ophthalmic Class 2 886.5925 2016-08-26

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.
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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
K851170 The Huxley Instrument Corp. DISSECTING TWEEZER #283-72PCS. SS 410 1985-04-25
K821248 Conphar, Inc. ROCHESTER PEAN FORCEPS 1982-05-28
K823222 American Medical Optics INTRAOCULAR LENS GUIDE 1982-12-28
K963512 Benz Research and Development Corp. BENZ B17 (KOLFOCON A) RIGID GAS PERMEABLE (HYDROPHOBIC DAILY WEAR CONTACT LENS (CLEAR AND TINTED, LATHE-CUT FROM LENS BL 1997-07-31
K163485 Adherium (Nz), Ltd. SmartTouch 2017-08-30

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0835-2025 Alcon Research LLC 1
Brand Name: Alcon Product Name: Monarch III D Delivery Cartridge Model/Catalog Number: 8065977763 Product Description: Monarch III D delivery cartridge Lens Guide, Intraocular Component: N/A
Z-0275-2012 Abbott Medical Optics Inc (AMO) 3
Sensar Foldable IOL with OptiEdge. Model number AR40e, 6.0 Diopter. The Sensar Foldable IOLs with OptiEdge Design are ultraviolet-absorbing posterior chamber intraocular lenses and are indicated for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens are intended to be placed in a capsular bag.
Z-0276-2012 Abbott Medical Optics Inc (AMO) 3
Sensar Foldable IOL with OptiEdge. Model number AR40e 21.5 Diopter. The Sensar Foldable IOLs with OptiEdge Design are ultraviolet-absorbing posterior chamber intraocular lenses and are indicated for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens are intended to be placed in a capsular bag.
Z-0605-2010 Abbott Medical Optics Inc (AMO) 3
AMO Tecnis 1-Piece Intraocular Lens (Model ZCB00)
Z-0929-2013 Abbott Medical Optics Inc (AMO) 3
AMO Sensar Intraocular Lenses (IOLs), Model AR40e, Sensar Foldable IOL with OptiEdge Product Usage: These are ultraviolet-absorbing posterior chamber intraocular lenses for use after cataract extraction.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1313525. Last updated year: 2026. Please use registration number 1313525 when referencing this establishment in official correspondence.
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