FDA Registration
Active
🇺🇸 United States
Bausch & Lomb Incorporated
Reg #: 1313525
·
FEI: 1317628
·
Expires 2026
Products
205
Proprietary Names
1
Establishment Types
4
Classifications
205
Registration Details
- Registration Name
- Bausch & Lomb Incorporated
- Registration Number
- 1313525
- FEI Number
- 1317628
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 1400 North Goodman Street
- City
- Rochester
- State
- NY
- ZIP
- 14609
- Country
- US
Regulatory Submissions
- 510(k) Number
- K063694
- PMA Number
- P910061
Owner / Operator
- Firm Name
- Bausch & Lomb Incorporated
- Operator Number
- 9913003
- Address
- 400 Somerset Corporate Blvd., --
- City
- Bridgewater
- State
- NJ
- Postal Code
- 08807
- Country
- US
- Correspondent
- Margaret Wood
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Forceps, General & Plastic Surgery | GEN | Class 1 | General, Plastic Surgery | No | 1993-01-01 |
| Lens, Guide, Intraocular | KYB | Class 1 | Ophthalmic | No | 2010-11-04 |
| Cutter, Wire | HXZ | Class 1 | Orthopedic | No | 1996-10-25 |
| Lens, Contact (Other Material) - Daily | HQD | Class 2 | Ophthalmic | No | 2023-01-19 |
| Intraocular Lens | HQL | Class 3 | Ophthalmic | No | 2008-01-17 |
| Nebulizer (Direct Patient Interface) | CAF | Class 2 | Anesthesiology | No | 2017-05-08 |
| Marker, Sclera | HMQ | Class 1 | Ophthalmic | No | 1997-01-08 |
| Catheter, Irrigation | GBX | Class 1 | General, Plastic Surgery | No | 2013-02-11 |
| Mirror, Headband, Ophthalmic | HKF | Class 1 | Ophthalmic | No | 2025-08-15 |
| Lens, Contact (Rigid Gas Permeable), Extended Wear | MWL | Class 3 | Ophthalmic | No | 2005-08-01 |
| Lens, Contact, Orthokeratology, Overnight | NUU | Class 3 | Ophthalmic | No | 2005-08-01 |
| Photocoagulator And Accessories | HQB | Class 2 | Ophthalmic | No | 2024-04-05 |
| Depressor, Orbital | HNX | Class 1 | Ophthalmic | No | 1996-10-01 |
| Folders And Injectors, Intraocular Lens (Iol) | MSS | Class 1 | Ophthalmic | No | 2012-12-13 |
| Products, Contact Lens Care, Rigid Gas Permeable | MRC | Class 2 | Ophthalmic | No | 2020-06-20 |
| System, Suction, Lipoplasty | MUU | Class 2 | General, Plastic Surgery | No | 2016-01-11 |
| Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat | IMI | Class 2 | Physical Medicine | No | 2016-01-11 |
| Massager, Therapeutic, Electric | ISA | Class 1 | Physical Medicine | No | 2016-01-11 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | Class 1 | Ophthalmic | No | 2005-08-29 |
| System, Suction, Lipoplasty For Removal | QPB | Class 2 | General, Plastic Surgery | No | 2016-01-11 |
| Accessories, Soft Lens Products | LPN | Class 2 | Ophthalmic | No | 2008-01-10 |
| Punch, Corneo-Scleral | HNJ | Class 1 | Ophthalmic | No | 1993-01-12 |
| Eye Tray | OJK | Class 2 | Ophthalmic | No | 2011-07-27 |
| Pack, Hot Or Cold, Reusable | IME | Class 1 | Physical Medicine | No | 2022-09-12 |
| Lenses, Soft Contact, Daily Wear | LPL | Class 2 | Ophthalmic | No | 2008-01-02 |
| Lenses, Soft Contact, Extended Wear | LPM | Class 3 | Ophthalmic | No | 2008-01-02 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2020-01-31 |
| Fluid, Intraocular | LWL | Class 3 | Ophthalmic | No | 2008-01-18 |
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | Class 2 | Orthopedic | No | 2025-09-24 |
| Laser, Ophthalmic | HQF | Class 2 | Ophthalmic | No | 2026-04-08 |
| Instrument, Vitreous Aspiration And Cutting, Ac-Powered | HQE | Class 2 | Ophthalmic | No | 2026-04-08 |
| Unit, Phacofragmentation | HQC | Class 2 | Ophthalmic | No | 2026-04-08 |
| Cannula, Nasal, Oxygen | CAT | Class 1 | Anesthesiology | No | 1993-01-01 |
| Collagen Corneal Shield | MOE | Class 1 | Ophthalmic | No | 2006-02-13 |
| Scissors, Wire Cutting, Ent, Sterile | JYA | Class 1 | Ear, Nose, Throat | No | 1993-01-01 |
| Osteotome, Manual | GFI | Class 1 | General, Plastic Surgery | No | 1993-01-01 |
| Gauge, Lens, Ophthalmic | HLN | Class 1 | Ophthalmic | No | 2025-05-13 |
| Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption | OHV | Class 2 | General, Plastic Surgery | No | 2016-01-11 |
| Mobilizer, Ent | KAJ | Class 1 | Ear, Nose, Throat | No | 1996-10-25 |
| Scissors, Ophthalmic | HNF | Class 1 | Ophthalmic | No | 2004-08-10 |
| Hook, Tracheal | KCH | Class 1 | Ear, Nose, Throat | No | 1993-01-01 |
| Loop, Wire | JYQ | Class 1 | Ear, Nose, Throat | No | 2025-04-29 |
| Endoilluminator | MPA | Class 2 | Gastroenterology, Urology | No | 2024-04-05 |
| Microscope, Operating, Non-Electric, Ophthalmic | HRB | Class 1 | General, Plastic Surgery | No | 2014-12-16 |
| Punch, Nasal | KAY | Class 1 | Ear, Nose, Throat | No | 1993-01-01 |
| Curette, Ophthalmic | HNZ | Class 1 | Ophthalmic | No | 1993-01-01 |
| Punch, Antrum | KAW | Class 1 | Ear, Nose, Throat | No | 1993-01-01 |
| Dissector, Tonsil | KBM | Class 1 | Ear, Nose, Throat | No | 1993-01-12 |
| Snare, Tonsil | KBZ | Class 1 | Ear, Nose, Throat | No | 1993-01-01 |
| Powered Laser Surgical Instrument With MicrobeamFractional Output | ONG | Class 2 | General, Plastic Surgery | No | 2016-01-11 |
| Media, Corneal Storage | LYX | Class U | Unknown | No | 2016-07-27 |
| Spatula, Ophthalmic | HND | Class 1 | Ophthalmic | No | 1993-01-01 |
| Spectacle, Magnifying | HOI | Class 1 | Ophthalmic | No | 2025-08-15 |
| Scissors, Orthopedic, Surgical | HRR | Class 1 | Orthopedic | No | 2025-08-04 |
| Study, Platelet Adhesive | JBZ | Class 2 | Hematology | No | 2025-08-04 |
| Razor, Surgical | LWK | Class 1 | General, Plastic Surgery | No | 2005-05-26 |
| Scissors, Nasal | KBD | Class 1 | Ear, Nose, Throat | No | 1993-01-01 |
| Knife, Ent | KTG | Class 1 | Ear, Nose, Throat | No | 1996-12-09 |
| Knife, Ophthalmic | HNN | Class 1 | Ophthalmic | No | 2005-08-29 |
| Trephine, Manual, Ophthalmic | HRH | Class 1 | Ophthalmic | No | 1993-01-01 |
| Gag, Mouth | KBN | Class 1 | Ear, Nose, Throat | No | 1993-01-01 |
| Curette, Adenoid | KBJ | Class 1 | Ear, Nose, Throat | No | 1993-01-01 |
| Syringe, Ent | KCP | Class 1 | Ear, Nose, Throat | No | 1993-01-01 |
| Speculum, Non-Illuminated | FXE | Class 1 | General, Plastic Surgery | No | 1993-01-01 |
| Barrier, Animal Source, Intraoral | NPL | Class 2 | Dental | No | 2016-09-19 |
| Needle, Ophthalmic Suturing | HNM | Class 1 | Ophthalmic | No | 1993-01-01 |
| Applicator, Ent | KCJ | Class 1 | Ear, Nose, Throat | No | 1993-01-01 |
| Spud, Ophthalmic | HNA | Class 1 | Ophthalmic | No | 1993-01-01 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 1996-12-09 |
| Tube, Tonsil Suction | KCB | Class 1 | Ear, Nose, Throat | No | 1993-01-01 |
| Mallet, Surgical, General & Plastic Surgery | GFJ | Class 1 | General, Plastic Surgery | No | 1993-01-01 |
| Crimper, Wire, Ent, Sterile | JXT | Class 1 | Ear, Nose, Throat | No | 1993-01-01 |
| Cannula, Surgical, General & Plastic Surgery | GEA | Class 1 | General, Plastic Surgery | No | 1996-11-05 |
| Powered Laser Surgical Instrument | GEX | Class 2 | General, Plastic Surgery | No | 2016-01-11 |
| Chisel, Nasal | KAN | Class 1 | General, Plastic Surgery | No | 1993-01-01 |
| Lens, Contact (Polymethylmethacrylate) | HPX | Class U | Unknown | No | 2008-01-14 |
| Aid, Surgical, Viscoelastic | LZP | Class 3 | Ophthalmic | No | 2023-04-07 |
| Cannula, Ophthalmic, Posterior Capsular Polishing, Polyvinyl Acetal | MXY | Class 1 | Ophthalmic | No | 2025-04-29 |
| Introducer, Sphere | HNP | Class 1 | Ophthalmic | No | 1993-01-01 |
| Block, Cutting, Ent, Sterile | JXS | Class 1 | Ear, Nose, Throat | No | 1993-01-01 |
| Needle, Gastro-Urology | FHR | Class 1 | General, Plastic Surgery | No | 2025-08-15 |
| Illuminator, Fiberoptic, Surgical Field | HBI | Class 2 | General, Plastic Surgery | No | 2008-01-24 |
| Rasp, Surgical, General & Plastic Surgery | GAC | Class 1 | General, Plastic Surgery | No | 1993-01-01 |
| Tape, Measuring, Rulers And Calipers | FTY | Class 1 | General, Plastic Surgery | No | 1993-01-01 |
| Hook, Ophthalmic | HNQ | Class 1 | Ophthalmic | No | 2005-08-29 |
| Aberrometer, Ophthalmic | NCF | Class 1 | Ophthalmic | No | 2002-04-12 |
| Punch, Adenoid | KBS | Class 1 | Ear, Nose, Throat | No | 1996-12-23 |
| Catheter And Tip, Suction | JOL | Class 2 | General Hospital | No | 1993-01-01 |
| Instruments, Surgical, Cardiovascular | DWS | Class 1 | Cardiovascular | No | 2013-03-22 |
| Guard, Instrument | LXZ | Class 1 | General, Plastic Surgery | No | 2025-08-15 |
| Tray, Surgical, Ent | MMO | Class 1 | Ear, Nose, Throat | No | 2013-02-01 |
| Pick, Microsurgical Ear | JYT | Class 1 | Ear, Nose, Throat | No | 1993-01-01 |
| Rasp, Ear | JYY | Class 1 | Ear, Nose, Throat | No | 1993-01-01 |
| Lens, Contact, (Disposable) | MVN | Class 2 | Ophthalmic | No | 2008-10-21 |
| Accessories, Solution, Ultrasonic Cleaners For Lenses | LYL | Class 2 | Ophthalmic | No | 2010-05-03 |
| Lens, Multifocal Intraocular | MFK | Class 3 | Ophthalmic | No | 2024-10-11 |
| Lens, Intraocular, Toric Optics | MJP | Class 3 | Ophthalmic | No | 2024-10-11 |
| Curette, Surgical, General Use | FZS | Class 1 | General, Plastic Surgery | No | 1993-01-01 |
| Gauge, Measuring | JYJ | Class 1 | Ear, Nose, Throat | No | 1993-01-01 |
| Probe | HXB | Class 1 | Orthopedic | No | 2013-02-01 |
| Marker, Ocular | HMR | Class 1 | Ophthalmic | No | 1996-11-05 |
| Bur, Ear, Nose And Throat | EQJ | Class 1 | Ear, Nose, Throat | No | 1993-01-01 |
| Needle, Aspiration And Injection, Reusable | GDM | Class 1 | General, Plastic Surgery | No | 1996-11-05 |
| Depressor, Metal Tongue, Surgical | KBL | Class 1 | Ear, Nose, Throat | No | 1993-01-01 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 1993-01-12 |
| Knife, Ear | JYO | Class 1 | Ear, Nose, Throat | No | 1993-01-01 |
| Burr, Corneal, Manual | HOF | Class 1 | Ophthalmic | No | 2005-08-29 |
| Cystotome | HNY | Class 1 | Ophthalmic | No | 2005-08-29 |
| Tubing, Pressure And Accessories | BYX | Class 1 | Anesthesiology | No | 2019-05-20 |
| Fork, Tuning | GWX | Class 1 | Neurology | No | 1996-12-10 |
| Case, Contact Lens | LRX | Class 2 | Ophthalmic | No | 2012-09-21 |
| Retractor, Self-Retaining | FFO | Class 1 | Gastroenterology, Urology | No | 2013-02-01 |
| Block, Cutting, Ent, Non-Sterile | NNR | Class 1 | Ear, Nose, Throat | No | 2025-08-04 |
| Pump, Infusion, Ophthalmic | MRH | Class 2 | General Hospital | No | 2024-08-12 |
| Scissors, General, Surgical | LRW | Class 1 | General, Plastic Surgery | No | 1996-09-09 |
| Needle, Suturing, Disposable | GAB | Class 1 | General, Plastic Surgery | No | 1993-01-01 |
| Rongeur, Lachrymal Sac | HNG | Class 1 | Ophthalmic | No | 1993-01-01 |
| Mirror, Ent | KAI | Class 1 | Ear, Nose, Throat | No | 1993-01-01 |
| Rongeur, Nasal | KBB | Class 1 | Ear, Nose, Throat | No | 1993-01-01 |
| Curette, Ear | JYG | Class 1 | Ear, Nose, Throat | No | 1993-01-01 |
| Syringe, Irrigating (Non Dental) | KYZ | Class 1 | General Hospital | No | 2024-03-11 |
| Elevator, Surgical, General & Plastic Surgery | GEG | Class 1 | General, Plastic Surgery | No | 1993-01-01 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2008-01-15 |
| Cannula, Ophthalmic | HMX | Class 1 | Ophthalmic | No | 2005-08-29 |
| Probe, Ent | KAK | Class 1 | Ear, Nose, Throat | No | 1993-01-01 |
| Cannula, Sinus | KAM | Class 1 | General, Plastic Surgery | No | 1993-01-01 |
| Tonometer, Manual | HKY | Class 2 | Ophthalmic | No | 2013-02-08 |
| Device, Irrigation, Ocular Surgery | KYG | Class 1 | Ophthalmic | No | 2023-07-18 |
| Chisel, Surgical, Manual | FZO | Class 1 | General, Plastic Surgery | No | 1993-01-01 |
| Perforator, Ear-Lobe | JYS | Class 1 | Ear, Nose, Throat | No | 2025-08-04 |
| Ring, Ophthalmic (Flieringa) | HNH | Class 1 | Ophthalmic | No | 2005-08-29 |
| Tube, Ear Suction | JZF | Class 1 | Ear, Nose, Throat | No | 1993-01-01 |
| Adenotome | KBH | Class 1 | Ear, Nose, Throat | No | 1993-01-01 |
| Scissors, Ear | JZB | Class 1 | Ear, Nose, Throat | No | 1993-01-01 |
| Probe, Lachrymal | HNL | Class 1 | Ophthalmic | No | 1993-01-01 |
| Holder, Needle, Gastroenterologic | FHQ | Class 1 | Gastroenterology, Urology | No | 1993-01-12 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 1993-01-01 |
| Needle, Tonsil Suturing | KBR | Class 1 | Ear, Nose, Throat | No | 1993-01-12 |
| Lens, Intraocular, Accommodative | NAA | Class 3 | Ophthalmic | No | 2008-03-12 |
| Cannula, Trocar, Ophthalmic | NGY | Class 1 | Ophthalmic | No | 2005-08-29 |
| Hook, Microsurgical Ear | JYL | Class 1 | Ear, Nose, Throat | No | 1993-01-01 |
| Snare, Enucleating | HNE | Class 1 | Ophthalmic | No | 1993-01-01 |
| Cannula, Injection | FGY | Class 1 | General, Plastic Surgery | No | 1993-01-01 |
| Forceps, Wire Closure, Ent, Sterile | JXX | Class 1 | Ear, Nose, Throat | No | 1993-01-01 |
| Bone Grafting Material, Animal Source | NPM | Class 2 | Dental | No | 2018-01-10 |
| Caliper, Ophthalmic | HOE | Class 1 | Ophthalmic | No | 1993-01-01 |
| Snare, Nasal | KBE | Class 1 | Ear, Nose, Throat | No | 1993-01-01 |
| Retractor, Ent | KAL | Class 1 | Ear, Nose, Throat | No | 1993-01-01 |
| Nipper, Malleus | JYR | Class 1 | Ear, Nose, Throat | No | 1993-01-01 |
| Dissector, Surgical, General & Plastic Surgery | GDI | Class 1 | General, Plastic Surgery | No | 1993-01-01 |
| Mallet | HXL | Class 1 | General, Plastic Surgery | No | 2025-08-04 |
| Specula, Ophthalmic | HNC | Class 1 | Ophthalmic | No | 2004-08-10 |
| Clamp, Muscle, Ophthalmic | HOB | Class 1 | Ophthalmic | No | 2004-08-10 |
| Knife, Surgical | EMF | Class 1 | General, Plastic Surgery | No | 1993-01-01 |
| Rasp, Nasal | KBA | Class 1 | Ear, Nose, Throat | No | 1993-01-01 |
| Ring, Endocapsular | MRJ | Class 3 | Unknown | No | 2018-03-13 |
| Hook, Surgical, General & Plastic Surgery | GDG | Class 1 | General, Plastic Surgery | No | 1993-01-01 |
| Lens, Contact (Orthokeratology) | MUW | Class 2 | Ophthalmic | No | 2008-01-09 |
| Staple, Removable (Skin) | GDT | Class 1 | General, Plastic Surgery | No | 1993-01-12 |
| Gouge, Surgical, General & Plastic Surgery | GDH | Class 1 | General, Plastic Surgery | No | 1996-10-01 |
| Knife, Tonsil | KBQ | Class 1 | Ear, Nose, Throat | No | 1993-01-01 |
| Conformer, Ophthalmic | HQN | Class 2 | Ophthalmic | No | 2006-05-12 |
| Punch, Surgical | LRY | Class 1 | General, Plastic Surgery | No | 1996-10-25 |
| Expressor | HNS | Class 1 | Ophthalmic | No | 1993-01-01 |
| Press, Vein | JYW | Class 1 | Ear, Nose, Throat | No | 2013-02-01 |
| Drape, Surgical, Exempt | PUI | Class 2 | General, Plastic Surgery | No | 2026-02-02 |
| Gouge, Nasal, Ent | KAQ | Class 1 | Ear, Nose, Throat | No | 1993-01-12 |
| Forceps, Tube Introduction | BWB | Class 1 | Anesthesiology | No | 1996-10-17 |
| Retractor, Ophthalmic | HNI | Class 1 | Ophthalmic | No | 2005-08-29 |
| Kit, Surgical Instrument, Disposable | KDD | Class 1 | General, Plastic Surgery | No | 2016-01-11 |
| Holder, Needle; Orthopedic | HXK | Class 1 | Orthopedic | No | 2025-01-27 |
| Elevator, Ent | KAD | Class 1 | Ear, Nose, Throat | No | 1993-01-01 |
| Bur, Surgical, General & Plastic Surgery | GFF | Class 1 | General, Plastic Surgery | No | 1993-01-01 |
| Syringe, Restorative And Impression Material | EID | Class 1 | Dental | No | 2013-02-01 |
| Holder, Speculum, Ent | KAG | Class 1 | General, Plastic Surgery | No | 1996-11-15 |
| Punch, Ent | KTF | Class 1 | Ear, Nose, Throat | No | 2013-02-01 |
| Probe, Radiofrequency Lesion | GXI | Class 2 | Neurology | No | 2010-07-23 |
| Trabeculotome | HMZ | Class 1 | Ophthalmic | No | 1993-01-01 |
| Forceps, Ophthalmic | HNR | Class 1 | Ophthalmic | No | 2004-08-10 |
| Snare, Ear | JZD | Class 1 | Ear, Nose, Throat | No | 1993-01-01 |
| Drape, Surgical, Antimicrobial | KKX | Class 2 | General, Plastic Surgery | No | 2008-01-15 |
| Tube, Laryngectomy | KAC | Class 1 | Ear, Nose, Throat | No | 1993-01-01 |
| Knife, Nasal | KAS | Class 1 | Ear, Nose, Throat | No | 1993-01-01 |
| Instrument, Ent Manual Surgical | LRC | Class 1 | Ear, Nose, Throat | No | 2013-02-01 |
| Compressor, Orbital | HOA | Class 1 | Ophthalmic | No | 2025-07-29 |
| Forceps, Ent | KAE | Class 1 | Ear, Nose, Throat | No | 1993-01-01 |
| Chisel, Middle-Ear | JYE | Class 1 | Ear, Nose, Throat | No | 1996-10-01 |
| Speculum, Ent | EPY | Class 1 | General, Plastic Surgery | No | 1993-01-01 |
| Curette | HTF | Class 1 | General, Plastic Surgery | No | 2013-02-01 |
| Trocar, Ent | KTE | Class 1 | Ear, Nose, Throat | No | 1996-12-10 |
| Clamp, Ossicle Holding | JYF | Class 1 | Ear, Nose, Throat | No | 1996-10-01 |
| Set, Laryngeal Injection | KAA | Class 1 | Ear, Nose, Throat | No | 2025-08-04 |
| Stripper, Surgical | HRT | Class 1 | Orthopedic | No | 1996-12-10 |
| Punch, Tonsil | KBT | Class 1 | Ear, Nose, Throat | No | 1993-01-01 |
| Curette, Nasal | KAP | Class 1 | Ear, Nose, Throat | No | 1993-01-01 |
| Dilator, Lachrymal | HNW | Class 1 | Ophthalmic | No | 1993-01-01 |
| Tube, Aspirating, Flexible, Connecting | BYY | Class 2 | General Hospital | No | 1997-01-08 |
| Tubing, Noninvasive | GAZ | Class 2 | General Hospital | No | 2006-05-12 |
| Extended Depth Of Focus Intraocular Lens | POE | Class 3 | Ophthalmic | No | 2023-04-27 |
| Spoon, Ophthalmic | HNB | Class 1 | Ophthalmic | No | 1993-01-01 |
| Clamp, Eyelid, Ophthalmic | HOD | Class 1 | Ophthalmic | No | 1989-02-22 |
| Handle, Scalpel | GDZ | Class 1 | General, Plastic Surgery | No | 2010-12-04 |
| Saliva, Artificial | LFD | Class U | Unknown | No | 2016-05-12 |
| Powered Light Based Non-Laser Surgical Instrument With Thermal Effect | ONF | Class 2 | General, Plastic Surgery | No | 2016-01-11 |
| Excavator, Ear | JYH | Class 1 | Ear, Nose, Throat | No | 1993-01-12 |
Proprietary Names
CX9626 25GA SYST -6/box
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device
Manufacture Device in the United States for Export Only