Profile: Luxtec produces medical illumination systems. We develop lighting and visualization systems for the operating room. Our products include headlights, ultralite, halogen, camera, surgical loupes, monitors, printers, and light sources. Our ultralite consists of ergonomic designs that use the head's natural contours to hold the light in place without uncomfortable pressure. Our MicroLux® DLX headlight camera system gives an entirely new way to visualize, edit, share and store surgical cases. Our adjustable surgical loupes make fitting easy and simplify the customization procedure to a minor movement of the loupe body. It requires neither time-consuming multiple fittings nor intrusive Pupillary Distance (PD) measurements. The frames can be fitted with prescription lenses and adjusted to fit the surgeon's PD on the spot. Our light source brings the brilliance of surgical lighting with the breakthrough CLX system, which is the first Xenon light source designed specifically for private practice, surgical centers and community hospitals. We develop lighting and visualization systems for the operating room.
The company was founded in 1981, has revenues of USD 10-25 Million, has ~140 employees and is ISO 9001, CE certified. NASDAQ:IART (SEC Filings)
• Tonsil Knife (FDA Code: KBQ / 874.4420) |
• Tonsil Punch (FDA Code: KBT / 874.4420) |
• Tonsil Screw (FDA Code: KBX / 874.4420) |
• Tonsil Snares (FDA Code: KBZ / 874.4420) |
• Tonsil Suction Tube (FDA Code: KCB / 874.4420) |
• Tonsil Suturing Needle (FDA Code: KBR / 874.4420) |
• Tracheal Bistoury (FDA Code: KCC / 874.4420) |
• Tracheal Dilators (FDA Code: KCG / 874.4420) |
• Tracheal Tube Cleaning Brushes (FDA Code: EPE / 868.5795) A tracheal tube cleaning brush is a device consisting of a brush with plastic bristles intended to clean tracheal cannula devices after their removal from patients. |
• Tracheal Tube with/without Connector (FDA Code: BTR / 868.5730) A tracheal tube is a device inserted into a patient's trachea via the nose or mouth and used to maintain an open airway. |
• Traction Splint (FDA Code: HSP / 888.5890) A noninvasive traction component is a device, such as a head halter, pelvic belt, or a traction splint, that does not penetrate the skin and is intended to assist in connecting a patient to a traction apparatus so that a therapeutic pulling force may be applied to the patient's body. |
• Tube Introduction Forceps (FDA Code: BWB / 868.5780) Tube introduction forceps (e.g., Magill forceps) are a right-angled device used to grasp a tracheal tube and place it in a patient's trachea. |
• Tuning Forks (FDA Code: GWX / 882.1525) A tuning fork is a mechanical device which resonates at a given frequency and is used to diagnose hearing disorders and to test for vibratory sense. |
• Two-point Discriminator (FDA Code: GWI / 882.1200) A two-point discriminator is a device with points used for testing a patient's touch discrimination. |
• Ultrasonic Surgical Instrument (FDA Code: LFL) |
• Umbilical Clamp And Cutter (FDA Code: NBZ / 884.4530) An obstetric-gynecologic specialized manual instrument is one of a group of devices used during obstetric-gynecologic procedures to perform manipulative diagnostic and surgical functions (e.g., dilating, grasping, measuring, and scraping), where structural integrity is the chief criterion of device performance. This type of device consists of the following: |
• Umbilical Scissors (FDA Code: HDJ / 884.4520) An obstetric-gynecologic general manual instrument is one of a group of devices used to perform simple obstetric and gynecologic manipulative functions. This generic type of device consists of the following: |
• Unipolar Endoscopic Coagulator-cutter and Accessories (FDA Code: KNF / 884.4160) A unipolar endoscopic coagulator-cutter is a device designed to destroy tissue with high temperatures by directing a high frequency electrical current through the tissue between an energized probe and a grounding plate. It is used in female sterilization and in other operative procedures under endoscopic observation. This generic type of device may include the following accessories: an electrical generator, probes and electrical cables, and a patient grounding plate. This generic type of device does not include devices used to perform female sterilization under hysteroscopic observation. |
• Urethral Catheters (FDA Code: GBM / 876.5130) A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudecatheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use). |
• Urethrotome (FDA Code: EZO / 876.4770) A urethrotome is a device that is inserted into the urethra and used to cut urethral strictures and enlarge the urethra. It is a metal instrument equipped with a dorsal-fin cutting blade which can be elevated from its sheath. Some urethrotomes incorporate an optical channel for visual control. |
• Urological Catheters (FDA Code: KOD / 876.5130) |
• Uterine Clamp (FDA Code: HGC / 884.4520) |
• Uterine Curettes (FDA Code: HCY / 884.4530) |
• Uterine Packer (FDA Code: HDM / 884.4520) |
• Uterine Sounds (FDA Code: HHM / 884.4530) |
• Uterine Tenaculum (FDA Code: HDC / 884.4530) |
• Vaginal Dilators (FDA Code: HDX / 884.3900) A vaginal stent is a device used to enlarge the vagina by stretching, or to support the vagina and to hold a skin graft after reconstructive surgery. |
• Vaginal Pessary (FDA Code: HHW / 884.3575) A vaginal pessary is a removable structure placed in the vagina to support the pelvic organs and is used to treat conditions such as uterine prolapse (falling down of uterus), uterine retroposition (backward displacement), or gynecologic hernia. |
• Vaginal Retractors (FDA Code: HDL / 884.4520) |
• Vascular Clamps (FDA Code: DXC / 870.4450) A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily. |
• Vein Press (FDA Code: JYW / 874.4420) |
• Ventricular Cannula (FDA Code: HCD / 882.4060) A ventricular cannula is a device used to puncture the ventricles of the brain for aspiration or for injection. This device is frequently referred to as a ventricular needle. |
• Video Camera Adapters |
• Visual Acuity Charts (FDA Code: HOX / 886.1150) A visual acuity chart is a device that is a chart, such as a Snellen chart with block letters or other symbols in graduated sizes, intended to test visual acuity. |
• Wire Cutters (FDA Code: HXZ / 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. |
• Wire Holding Forceps (FDA Code: HYA / 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. |
• Wire Loop (FDA Code: JYQ / 874.4420) |
• Wire Twisters (FDA Code: HXS / 888.4540) |
• Xenon Arc Endoscope Light Source (FDA Code: GCT / 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. |