Cystotome Suppliers
Limit companies to: Worldwide USA
Oasis Medical, Inc. | Address: 510-528 S. Vermont Ave., Glendora, California 91741, USA 
www.oasismedical.com | Send Inquiry | Phone: +1-(909)-305-5400
FDA Registration: 2083373 Year Established: 1987 Annual Revenues: USD 10-25 Million Employee Count: ~60 Quality: ISO 9001, CE Certified
Products: Lacrimal Dilators and Cannulas, MVR Blades, Punctum Plugs (Punctal Plugs), Absorbing Supplies, Stab Blades, Tunnel Knives, ...
Oasis Medical, Inc. manufactures and markets eye care products for ophthalmic & optometric professionals. We offer products such as cataract, dry eye, refractive, retinal & accessories. Our own tradem more...
www.oasismedical.com | Send Inquiry | Phone: +1-(909)-305-5400
FDA Registration: 2083373 Year Established: 1987 Annual Revenues: USD 10-25 Million Employee Count: ~60 Quality: ISO 9001, CE Certified
Products: Lacrimal Dilators and Cannulas, MVR Blades, Punctum Plugs (Punctal Plugs), Absorbing Supplies, Stab Blades, Tunnel Knives, ...
Oasis Medical, Inc. manufactures and markets eye care products for ophthalmic & optometric professionals. We offer products such as cataract, dry eye, refractive, retinal & accessories. Our own tradem more...
Hurricane Medical | Address: 2331K 63rd Avenue East, Bradenton, Florida 34203, USA
www.hurricanemedical.com | Send Inquiry | Phone: +1-(941)-751-0588
FDA Registration: 1064005
Products: Manipulators, Rotators, Spatulas and Picks, Disposables, Irrigating Cannulas, Cystotome Needles, Intraocular Lens Manipulators, Punctal Irrigation Cannulas, ...
Hurricane Medical manufactures surgical products. We offer services to ophthalmic professionals. Our lasik irrigators are designed to irrigate the corneal interface & stronial bed. We are accredited w more...
www.hurricanemedical.com | Send Inquiry | Phone: +1-(941)-751-0588
FDA Registration: 1064005
Products: Manipulators, Rotators, Spatulas and Picks, Disposables, Irrigating Cannulas, Cystotome Needles, Intraocular Lens Manipulators, Punctal Irrigation Cannulas, ...
Hurricane Medical manufactures surgical products. We offer services to ophthalmic professionals. Our lasik irrigators are designed to irrigate the corneal interface & stronial bed. We are accredited w more...
Medtronic Xomed Surgical Products, Inc | Address: 6743 Southpoint Drive North, Jacksonville, Florida 32216-0980, USA
www.xomed.com | Phone: +1-(904)-296-9600, 800-874-5797
FDA Registration: 1045254 Year Established: 1999 Annual Revenues: USD 500 Million to 1 Billion Employee Count: ~650 Quality: ISO 9001, CE Certified
Products: Sinus Trochars and Cannulae, Surgical Navigation Interface/Display, Nerve Stimulators, Eyeshields, General Diagnostic Supplies, General Surgical Aids, ...
Medtronic Xomed Surgical Products, Inc develops products that treat people with ear, nose and throat (ENT) diseases. our products include MeroPack®, Bioresorbable Nasal Dressing and Sinus Stent, I more...
www.xomed.com | Phone: +1-(904)-296-9600, 800-874-5797
FDA Registration: 1045254 Year Established: 1999 Annual Revenues: USD 500 Million to 1 Billion Employee Count: ~650 Quality: ISO 9001, CE Certified
Products: Sinus Trochars and Cannulae, Surgical Navigation Interface/Display, Nerve Stimulators, Eyeshields, General Diagnostic Supplies, General Surgical Aids, ...
Medtronic Xomed Surgical Products, Inc develops products that treat people with ear, nose and throat (ENT) diseases. our products include MeroPack®, Bioresorbable Nasal Dressing and Sinus Stent, I more...
Medone Surgical, Inc. | Address: 670 Tallevast Road, Sarasota, Florida 34243, USA
www.medone.com | Send Inquiry | Phone: +1-(941)-359-3129, 866-633-6631
FDA Registration: 3014197664
Products: Retinal Brushes, Vertical Microscissors, Angled Micro Capsulorhexis Forceps, Neurosurgery, Rotary Instruments, Titanium Micro Forceps, Micro Scissors, ...
Medone Surgical, Inc. manufactures & markets surgical products. We are an ISO certified company. We offer products for retina surgery, cannulas related accessory products, including FlexTip™Cann more...
www.medone.com | Send Inquiry | Phone: +1-(941)-359-3129, 866-633-6631
FDA Registration: 3014197664
Products: Retinal Brushes, Vertical Microscissors, Angled Micro Capsulorhexis Forceps, Neurosurgery, Rotary Instruments, Titanium Micro Forceps, Micro Scissors, ...
Medone Surgical, Inc. manufactures & markets surgical products. We are an ISO certified company. We offer products for retina surgery, cannulas related accessory products, including FlexTip™Cann more...
Rhein Medical Inc. | Address: 5460 Beaumont Center Blvd,Suite 500, Tampa, Florida 33634, USA
www.rheinmedical.com | Send Inquiry | Phone: +1-(813)-885-5050
FDA Registration: 1051791 Year Established: 1988 Annual Revenues: USD 1-5 Million Employee Count: ~20 Quality: ISO 9000, ISO 9001, ISO 9002, ISO 9003, CE Certified
Products: Binkhorst, IOL Inserters, Surgical Restraint Systems, Diamond Knives, Binkhorst Irrigating Cannula, Binkhorst Hooked Cannula, ...
Rhein Medical Inc. designs, develops and distributes specialized hand-held ophthalmic surgical instruments. Our products include 3-D Bi-Manual phaco blade, Rhein colbri capsulorhexis forceps, tubular more...
www.rheinmedical.com | Send Inquiry | Phone: +1-(813)-885-5050
FDA Registration: 1051791 Year Established: 1988 Annual Revenues: USD 1-5 Million Employee Count: ~20 Quality: ISO 9000, ISO 9001, ISO 9002, ISO 9003, CE Certified
Products: Binkhorst, IOL Inserters, Surgical Restraint Systems, Diamond Knives, Binkhorst Irrigating Cannula, Binkhorst Hooked Cannula, ...
Rhein Medical Inc. designs, develops and distributes specialized hand-held ophthalmic surgical instruments. Our products include 3-D Bi-Manual phaco blade, Rhein colbri capsulorhexis forceps, tubular more...
Luxtec | Address: 99 Hartwell Street, West Boylston, Maryland 01583, USA
www.luxtec.com | Send Inquiry | Phone: +1-(508)-835-9700
Year Established: 1981 Annual Revenues: USD 10-25 Million Employee Count: ~140 Quality: ISO 9001, CE Certified
Products: Light Sources, Surgical Headlights, Recording Systems, Headlight Box / Light source, Digital Video Recorders, Recording Devices, ...
Luxtec produces medical illumination systems. We develop lighting and visualization systems for the operating room. Our products include headlights, ultralite, halogen, camera, surgical loupes, monito more...
www.luxtec.com | Send Inquiry | Phone: +1-(508)-835-9700
Year Established: 1981 Annual Revenues: USD 10-25 Million Employee Count: ~140 Quality: ISO 9001, CE Certified
Products: Light Sources, Surgical Headlights, Recording Systems, Headlight Box / Light source, Digital Video Recorders, Recording Devices, ...
Luxtec produces medical illumination systems. We develop lighting and visualization systems for the operating room. Our products include headlights, ultralite, halogen, camera, surgical loupes, monito more...
Teleflex Medical | Address: PO Box 12600, Research Triangle Park, North Carolina 27709, USA
www.teleflexmedical.com | Send Inquiry | Phone: +1-(919)-544-8000
FDA Registration: 1044475 Annual Revenues: USD 50-100 Million Employee Count: ~380 Quality: ISO 9001, CE Certified
Products: Absorbable Sutures (FDA Code: GAK), General Diagnostic Supplies, General Medical Supplies, General Sutures/Needles, Non-Absorbable Sutures (FDA Code: GAO), Suture Needles, ...
Teleflex Medical, a division of Teleflex Incorporated, is a supplier of medical devices, surgical instruments & disposable medical products. We are a global outsource provider that focuses on medical more...
www.teleflexmedical.com | Send Inquiry | Phone: +1-(919)-544-8000
FDA Registration: 1044475 Annual Revenues: USD 50-100 Million Employee Count: ~380 Quality: ISO 9001, CE Certified
Products: Absorbable Sutures (FDA Code: GAK), General Diagnostic Supplies, General Medical Supplies, General Sutures/Needles, Non-Absorbable Sutures (FDA Code: GAO), Suture Needles, ...
Teleflex Medical, a division of Teleflex Incorporated, is a supplier of medical devices, surgical instruments & disposable medical products. We are a global outsource provider that focuses on medical more...
KMI Surgical, Ltd. | Address: Laird Professional Building, 110 Hopewell Road, Downingtown, Pennsylvania 19335, USA
www.kmisurgical.com | Phone: +1-(610)-518-7110
Annual Revenues: USD 5-10 Million Employee Count: ~20
Products: Diamond Knives, General Surgical Instruments, Instruments surgical, Ophthalmology Surgical Instrument Stands, Ophthalmic Cannula (FDA Code: HMX), Surgical Ophthalmic Cannula (FDA Code: HMX), ...
KMI Surgical, Ltd. provides mainly ophthalmic surgical instruments, diamond knives and anesthesia disposables. more...
www.kmisurgical.com | Phone: +1-(610)-518-7110
Annual Revenues: USD 5-10 Million Employee Count: ~20
Products: Diamond Knives, General Surgical Instruments, Instruments surgical, Ophthalmology Surgical Instrument Stands, Ophthalmic Cannula (FDA Code: HMX), Surgical Ophthalmic Cannula (FDA Code: HMX), ...
KMI Surgical, Ltd. provides mainly ophthalmic surgical instruments, diamond knives and anesthesia disposables. more...
Miltex, Inc. | Address: 589 Davies Drive, York, Pennsylvania 17402, USA
www.miltex.com | Send Inquiry | Phone: +1-(717)-840-9335
FDA Registration: 2523190 Year Established: 1950 Employee Count: ~200 Quality: ISO 9001, CE Certified
Products: Forceps (FDA Code: HTD), Scissors, Vasectomy Ringed Forceps, Vasectomy Hemostats, General Medical Supplies, General Surgical Instruments, ...
Miltex, Inc. specializes in surgical and dental instruments. Our product line includes surgical, dental, gynecology, animal health, podiatry and repair instruments. Our Miltex® endometrial samplin more...
www.miltex.com | Send Inquiry | Phone: +1-(717)-840-9335
FDA Registration: 2523190 Year Established: 1950 Employee Count: ~200 Quality: ISO 9001, CE Certified
Products: Forceps (FDA Code: HTD), Scissors, Vasectomy Ringed Forceps, Vasectomy Hemostats, General Medical Supplies, General Surgical Instruments, ...
Miltex, Inc. specializes in surgical and dental instruments. Our product line includes surgical, dental, gynecology, animal health, podiatry and repair instruments. Our Miltex® endometrial samplin more...
Surgistar Inc. | Address: 820 Corridor Park Blvd, Knoxville, Tennessee 37932, USA
www.surgistar.com | Send Inquiry | Phone: +1-(865)-671-4300
FDA Registration: 2028661 Year Established: 1992 Annual Revenues: USD 5-10 Million Employee Count: ~40 Quality: ISO 9001 Certified
Products: Sickle Blades, MVR Blades, Trabeculectomy Blades, Neck Supplies, Blades and Knives, Tunnel Blades, Cannulas, ...
Surgistar, Inc. is a manufacturer of single use ophthalmic, ENT and surgical products. Our ophthalmology products include knives, blades, cannulas, microkeratome blades, tubing, and corneal trephines. more...
www.surgistar.com | Send Inquiry | Phone: +1-(865)-671-4300
FDA Registration: 2028661 Year Established: 1992 Annual Revenues: USD 5-10 Million Employee Count: ~40 Quality: ISO 9001 Certified
Products: Sickle Blades, MVR Blades, Trabeculectomy Blades, Neck Supplies, Blades and Knives, Tunnel Blades, Cannulas, ...
Surgistar, Inc. is a manufacturer of single use ophthalmic, ENT and surgical products. Our ophthalmology products include knives, blades, cannulas, microkeratome blades, tubing, and corneal trephines. more...
Boss Instruments, Ltd. | Address: 395 Reas Ford Road, Suite 120, Earlysville, Virginia 22936, USA
www.bossinst.com | Send Inquiry | Phone: +1-(800)-210-2677
FDA Registration: 1056350 Year Established: 1990 Annual Revenues: < USD 1 Million Employee Count: ~10 Quality: ISO 9000, ISO 9002, CE Certified
Products: Tissue Forceps, Sinus Trochars and Cannulae, Tourniquets, Vascular Clamps (FDA Code: DXC), Adjustable Bone Holding Forceps, Dilators, ...
Boss Instruments, Ltd. is a surgical instrument company which concentrates on the manufacture and continual development of specialty lines of instruments include ear, nose, and throat, general surgery more...
www.bossinst.com | Send Inquiry | Phone: +1-(800)-210-2677
FDA Registration: 1056350 Year Established: 1990 Annual Revenues: < USD 1 Million Employee Count: ~10 Quality: ISO 9000, ISO 9002, CE Certified
Products: Tissue Forceps, Sinus Trochars and Cannulae, Tourniquets, Vascular Clamps (FDA Code: DXC), Adjustable Bone Holding Forceps, Dilators, ...
Boss Instruments, Ltd. is a surgical instrument company which concentrates on the manufacture and continual development of specialty lines of instruments include ear, nose, and throat, general surgery more...
Medical Sterile Products | Address: PO Box 338, Rincon 00743, USA
Phone: +1-(787)-823-2595, 800-292-2887
Year Established: 1963 Employee Count: ~80 Quality: ISO 9001, CE Certified
Products: Scalpel Handle (FDA Code: GDZ), Miniature Blades, Disposable Surgical Knives, Disposable Surgical Blades, Scalpel Blade (FDA Code: GES), Cardiovascular Surgical Saw Blade (FDA Code: DWH), ...
Medical Sterile Products deals with disposable & reusable surgical blades & knives, miniature edged blades, oral-perio blades, arthro blades, podiatry blades, and oral-perio handles. more...
Phone: +1-(787)-823-2595, 800-292-2887
Year Established: 1963 Employee Count: ~80 Quality: ISO 9001, CE Certified
Products: Scalpel Handle (FDA Code: GDZ), Miniature Blades, Disposable Surgical Knives, Disposable Surgical Blades, Scalpel Blade (FDA Code: GES), Cardiovascular Surgical Saw Blade (FDA Code: DWH), ...
Medical Sterile Products deals with disposable & reusable surgical blades & knives, miniature edged blades, oral-perio blades, arthro blades, podiatry blades, and oral-perio handles. more...
Instrumed International, Inc. | Address: 626 Cooper Court, Schaumburg, Illinois 60173, USA
www.instrumedinc.biz | Phone: +1-(847)-908-0292
FDA Registration: 1421101
Products: Laparoscopic Equipment, Retractor System, General Surgical Instruments, Titanium Microsurgical Instruments, Orthopedic Instruments, Maxillofacial Prosthesis, ...
Instrumed International, Inc. specializes in providing reusable surgical instruments. We offer surgical products for bipolar, CV/thoracic, ENT, general, hand & micro surgery, laparoscopic, laryngeal, more...
www.instrumedinc.biz | Phone: +1-(847)-908-0292
FDA Registration: 1421101
Products: Laparoscopic Equipment, Retractor System, General Surgical Instruments, Titanium Microsurgical Instruments, Orthopedic Instruments, Maxillofacial Prosthesis, ...
Instrumed International, Inc. specializes in providing reusable surgical instruments. We offer surgical products for bipolar, CV/thoracic, ENT, general, hand & micro surgery, laparoscopic, laryngeal, more...
Ophthalmic Surgical LLC | Address: 76825 Jessie Romig Dr., Grosse Tete, Louisiana 70740, USA
www.ophthalmicsurgical.com | Send Inquiry | Phone: +1-(225)-921-0971
Products: Lacrimal Probes (FDA Code: HNL), Lacrimal Dilator (FDA Code: HNW), Corneal Radius Measurement Instrument (FDA Code: HJB), Corneo-Scleral Punch (FDA Code: HNJ), Intraocular Lens Guide (FDA Code: KYB), Iris Retractor Clip (FDA Code: HOC), ...
Ophthalmic Surgical LLC is engaged in the production of surgical instruments. Our products include calipers and gauges, cannulas, DCR instruments, diamond knives, enucleation & evisceration instrument more...
www.ophthalmicsurgical.com | Send Inquiry | Phone: +1-(225)-921-0971
Products: Lacrimal Probes (FDA Code: HNL), Lacrimal Dilator (FDA Code: HNW), Corneal Radius Measurement Instrument (FDA Code: HJB), Corneo-Scleral Punch (FDA Code: HNJ), Intraocular Lens Guide (FDA Code: KYB), Iris Retractor Clip (FDA Code: HOC), ...
Ophthalmic Surgical LLC is engaged in the production of surgical instruments. Our products include calipers and gauges, cannulas, DCR instruments, diamond knives, enucleation & evisceration instrument more...
Becton Dickinson And Co. | Address: 411 Waverley Oaks Rd., Waltham, Massachusetts 02452-8405, USA
www.bd.com/ophthalmology | Send Inquiry | Phone: +1-(781)-906-7900, 866-906-8080
FDA Registration: 1211998 Annual Revenues: USD 10-25 Million Employee Count: ~200
Products: Disposable Ophthalmic Cannulae, Dissecting Scalpel Blades, Cataract Knife, Culture Media Supplements (FDA Code: JSK), Cystotome (FDA Code: HNY), Bone Cutting Blade, ...
Our products focus on cataract, refractive, surgery kits and other surgical products. Our cataract products include blades, knives, cannules, cystotomes, drapes, and fluid collection. Our surgical pro more...
www.bd.com/ophthalmology | Send Inquiry | Phone: +1-(781)-906-7900, 866-906-8080
FDA Registration: 1211998 Annual Revenues: USD 10-25 Million Employee Count: ~200
Products: Disposable Ophthalmic Cannulae, Dissecting Scalpel Blades, Cataract Knife, Culture Media Supplements (FDA Code: JSK), Cystotome (FDA Code: HNY), Bone Cutting Blade, ...
Our products focus on cataract, refractive, surgery kits and other surgical products. Our cataract products include blades, knives, cannules, cystotomes, drapes, and fluid collection. Our surgical pro more...
Micromachining Technologies, Inc. | Address: 2345 Millpark Dr., Suite A, Maryland Heights, Missouri 63043, USA
Phone: +1-(314)-785-6800
Products: Cystotome (FDA Code: HNY), ...
Micromachining Technologies, Inc. is a manufacturer of disposable anterior capsulotomy cystotome. more...
Phone: +1-(314)-785-6800
Products: Cystotome (FDA Code: HNY), ...
Micromachining Technologies, Inc. is a manufacturer of disposable anterior capsulotomy cystotome. more...
Rhein Mfg., Inc. | Address: 2269 Grissom Dr., St. Louis, Missouri 63146, USA
Phone: +1-(314)-997-1775
FDA Registration: 1932214
Products: Forceps (FDA Code: HTD), Ophthalmic Forceps (FDA Code: HNR), Disposable Aspiration and Injection Needle (FDA Code: GAA), General & Plastic Surgery Forceps (FDA Code: GEN), General & Plastic Surgery Surgical Clamp (FDA Code: GDJ), General Surgical Scissors (FDA Code: LRW), ...
Rhein Mfg., Inc. specializes in general surgical instruments, ophthalmic surgical forceps and endoscopic surgical instruments. more...
Phone: +1-(314)-997-1775
FDA Registration: 1932214
Products: Forceps (FDA Code: HTD), Ophthalmic Forceps (FDA Code: HNR), Disposable Aspiration and Injection Needle (FDA Code: GAA), General & Plastic Surgery Forceps (FDA Code: GEN), General & Plastic Surgery Surgical Clamp (FDA Code: GDJ), General Surgical Scissors (FDA Code: LRW), ...
Rhein Mfg., Inc. specializes in general surgical instruments, ophthalmic surgical forceps and endoscopic surgical instruments. more...
Katena Products, Inc. | Address: 4 Stewart Ct., Denville, New Jersey 07834, USA
www.katena.com | Send Inquiry | Phone: +1-(973)-989-1600, 800-225-1195
FDA Registration: 2242450 Year Established: 1975 Annual Revenues: USD 10-25 Million Employee Count: ~20 Quality: ISO 13485, CE Certified
Products: Trephines, Punches, Diamond Knives, Disposable Blades, Corneal Markers, IOL Manipulator, ...
Katena Products, Inc. deals with ophthalmic surgical instrumentation. Our product categories are corneal markers, disposable knives, forceps, lasik instruments, phaco choppers, scissors and spatulas. more...
www.katena.com | Send Inquiry | Phone: +1-(973)-989-1600, 800-225-1195
FDA Registration: 2242450 Year Established: 1975 Annual Revenues: USD 10-25 Million Employee Count: ~20 Quality: ISO 13485, CE Certified
Products: Trephines, Punches, Diamond Knives, Disposable Blades, Corneal Markers, IOL Manipulator, ...
Katena Products, Inc. deals with ophthalmic surgical instrumentation. Our product categories are corneal markers, disposable knives, forceps, lasik instruments, phaco choppers, scissors and spatulas. more...
Alcon Manufacturing, Ltd. | Address: 714 Columbia Ave., Sinking Spring, Pennsylvania 19608, USA
www.alcon.com | Phone: +1-(610)-670.3500
FDA Registration: 2523835
Products: Disposable Irrigating Syringe, Enteral Irrigation Kit w/Piston Syringe, Piston Syringe (FDA Code: FMF), Non Dental Irrigating Syringe (FDA Code: KYZ), Ophthalmic Cannula (FDA Code: HMX), Surgical Ophthalmic Cannula (FDA Code: HMX), ...
Alcon Manufacturing, Ltd. is a provider of eye care products. We develop, manufacture and market surgical equipment & devices, pharmaceutical eye drops & consumer vision care products to treat eye dis more...
www.alcon.com | Phone: +1-(610)-670.3500
FDA Registration: 2523835
Products: Disposable Irrigating Syringe, Enteral Irrigation Kit w/Piston Syringe, Piston Syringe (FDA Code: FMF), Non Dental Irrigating Syringe (FDA Code: KYZ), Ophthalmic Cannula (FDA Code: HMX), Surgical Ophthalmic Cannula (FDA Code: HMX), ...
Alcon Manufacturing, Ltd. is a provider of eye care products. We develop, manufacture and market surgical equipment & devices, pharmaceutical eye drops & consumer vision care products to treat eye dis more...
Bausch & Lomb Inc. | Address: 8507 Pelham Rd., Greenville, South Carolina 29615-9598, USA
Phone: +1-(585)-338-6000
FDA Registration: 1032500
Products: Contact Lens (FDA Code: HQD), Contact Lens Case, Container (FDA Code: LRX), ENT Forceps (FDA Code: KAE), Soft Lens Accessories (FDA Code: LPN), Contact Extended Wear Lens (FDA Code: MWL), Contact Lens (Disposable) (FDA Code: MVN), ...
Bausch & Lomb Inc. specializes in offering contact lens and contact lens care products. more...
Phone: +1-(585)-338-6000
FDA Registration: 1032500
Products: Contact Lens (FDA Code: HQD), Contact Lens Case, Container (FDA Code: LRX), ENT Forceps (FDA Code: KAE), Soft Lens Accessories (FDA Code: LPN), Contact Extended Wear Lens (FDA Code: MWL), Contact Lens (Disposable) (FDA Code: MVN), ...
Bausch & Lomb Inc. specializes in offering contact lens and contact lens care products. more...
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FDA Code / Regulation: HNY / 886.4350
A manual ophthalmic surgical instrument is a nonpowered, handheld device intended to aid or perform ophthalmic surgical procedures. This generic type of device includes the manual corneal burr, ophthalmic caliper, ophthalmic cannula, eyelid clamp, ophthalmic muscle clamp, iris retractor clip, orbital compressor, ophthalmic curette, cystotome, orbital depressor, lachrymal dilator, erisophake, expressor, ophthalmic forcep, ophthalmic hook, sphere introducer, ophthalmic knife, ophthalmic suturing needle, lachrymal probe, trabeculotomy probe, cornea-sclera punch, ophthalmic retractor, ophthalmic ring (Flieringa), lachrymal sac rongeur, ophthalmic scissors, enucleating snare, ophthalmic spatula, ophthalmic specula, ophthalmic spoon, ophthalmic spud, trabeculotome or ophthalmic manual trephine.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 886.9.
