Profile: Insight Instruments, Inc. specializes in production, development and sale of instruments to vitreo retinal surgeons. Our BIOM 3 incorporates the principle of indirect opthalmoscopy in the operating microscope and enables a view of almost 130 degrees of non- contact fundus observation. Under the BIOM 3, the eye may be rotated freely so that the extreme periphery can be easily viewed. Our SuperView® disposable provides 130 degree field of view as compared to previous BIOM lenses. Additionally, since they are one time use, the surgeon will experience a crystal clear view every case without unavoidable scratches and sterilization spots associated with reusable glass lenses. Time savings are also realized by avoiding the significant downtime experienced by sterilization systems utilized by many of today's operating rooms. Our full coverage microscope drape provides the safety and peace of mind of full field sterility. Our self-sealing feature allows the surgeon to enter and exit the port without the need for plugs
The company has revenues of USD 1-5 Million.
FDA Registration Number: 1052234
18 Products/Services (Click for related suppliers)
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| • Battery-Powered Vitreous Aspiration and Cutting Instrument (FDA Code: HKP / 886.4150) A vitreous aspiration and cutting instrument is an electrically powered device, which may use ultrasound, intended to remove vitreous matter from the vitreous cavity or remove a crystalline lens. |
| • Corneo-Scleral Punch (FDA Code: HNJ / 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. |
| • Diagnostic Condensing Lens (FDA Code: HJL / 886.1380) A diagnostic condensing lens is a device used in binocular indirect ophthalmoscopy (a procedure that produces an inverted or reversed direct magnified image of the eye) intended to focus reflected light from the fundus of the eye. |
| • Diagnostic Polymethylmethacrylate Contact Lens (FDA Code: HJK / 886.1385) A polymethylmethacrylate (PMMA) diagnostic contact lens is a device that is a curved shell of PMMA intended to be applied for a short period of time directly on the globe or cornea of the eye for diagnosis or therapy of intraocular abnormalities. |
| • Diagnostic/Surgical Loupe (FDA Code: FSP / 878.4800) A manual surgical instrument for general use is a nonpowered, hand-held, or hand-manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, blood lancet, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892. |
| • Disposable Ophthalmic Cannulae |
| • Lens |
| • Ocular Surgery Irrigation Device (FDA Code: KYG / 886.4360) An ocular surgery irrigation device is a device intended to be suspended over the ocular area during ophthalmic surgery to deliver continuous, controlled irrigation to the surgical field. |
| • Ophthalmic Aspiration Cannula (FDA Code: HMX / 886.4350) |
| • Ophthalmic Cannula (FDA Code: HMX / 886.4350) |
| • Ophthalmic Endoscope (FDA Code: KYH / 876.1500) An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations. |
| • Ophthalmic Forceps (FDA Code: HNR / 886.4350) |
| • Ophthalmic Trocar Cannula (FDA Code: NGY / 886.4350) |
| • Probes (FDA Code: HXB / 888.4540) An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. This generic type of device includes the cerclage applier, awl, bender, drill brace, broach, burr, corkscrew, countersink, pin crimper, wire cutter, prosthesis driver, extractor, file, fork, needle holder, impactor, bending or contouring instrument, compression instrument, passer, socket positioner, probe, femoral neck punch, socket pusher, reamer, rongeur, scissors, screwdriver, bone skid, staple driver, bone screw starter, surgical stripper, tamp, bone tap, trephine, wire twister, and wrench. |
| • Safety Drape |
| • Sterile Microscope Drapes |
| • Surgical Microscopes (FDA Code: EPT / 878.4700) A surgical microscope and accessories is an AC-powered device intended for use during surgery to provide a magnified view of the surgical field. |
| • Surgical Ophthalmic Cannula (FDA Code: HMX / 886.4350) |