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)

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• General use Surgical Curettes (FDA Code: FZS / 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.

• Graduated Liquid Medication Container (FDA Code: KYW / 880.6430) A Liquid medication dispenser is a device intended for medical purposes that is used to issue a measured amount of liquid medication.

• Guiding Probes

• Gynecologic Electrocautery and Accessories (FDA Code: HGI / 884.4120) A gynecologic electrocautery is a device designed to destroy tissue with high temperatures by tissue contact with an electrically heated probe. It is used to excise cervical lesions, perform biopsies, or treat chronic cervicitis under direct visual observation. This generic type of device may include the following accessories: an electrical generator, a probe, and electrical cables.

• Gynecologic Laparoscope and Accessories (FDA Code: HET / 884.1720) A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.

• Gynecological Biopsy Forceps (FDA Code: HFB / 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:

• Gynecological Fibroid Screw (FDA Code: HHO / 884.4530)

• Gynecological Surgical Forceps (FDA Code: HCZ / 884.4530)

• Hand Splint and Component (FDA Code: ILH / 890.3475) A limb orthosis (brace) is a device intended for medical purposes that is worn on the upper or lower extremities to support, to correct, or to prevent deformities or to align body structures for functional improvement. Examples of limb orthoses include the following: A whole limb and joint brace, a hand splint, an elastic stocking, a knee cage, and a corrective shoe.

• Hard Tissue Biodegradable Fixation Fastener (FDA Code: MBJ)

• Headlight Box / Light source

• Hemorrhoidal Ligator (FDA Code: FHN / 876.4400) A hemorrhoidal ligator is a device used to cut off the blood flow to hemorrhoidal tissue by means of a ligature or band placed around the hemorrhoid.

• Hemostatic Clip Applier (FDA Code: HBT / 878.4800)

• Hemostats (FDA Code: HRQ / 878.4800)

• High Resolution Microscope Video Cameras

• Hook-type Contraceptive Intrauterine Device Remover (FDA Code: HHF / 884.4530)

• Human Bone Rasps (FDA Code: HTR / 878.4800)

• Impactor (FDA Code: HWA / 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.

• Infant Tongue Depressor (FDA Code: FMA / 880.6230) A tongue depressor is a device intended to displace the tongue to facilitate examination of the surrounding organs and tissues.

• Instestinal Clamp Locking Device (FDA Code: FFR / 876.4730) A manual gastroenterology-urology surgical instrument and accessories is a device designed to be used for gastroenterological and urological surgical procedures. The device may be nonpowered, hand-held, or hand-manipulated. Manual gastroenterology-urology surgical instruments include the biopsy forceps cover, biopsy tray without biopsy instruments, line clamp, nonpowered rectal probe, nonelectrical clamp, colostomy spur-crushers, locking device for intestinal clamp, needle holder, gastro-urology hook, gastro-urology probe and director, nonself-retaining retractor, laparotomy rings, nonelectrical snare, rectal specula, bladder neck spreader, self-retaining retractor, and scoop.

• Instrument Surgical Guide (FDA Code: FZX / 878.4800)

• Interactive Wound and Burn Dressing (FDA Code: MGR)

• Intramedullary Fixation Rod and Accessories (FDA Code: HSB / 888.3020) An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.

• Intraventricular Subcutaneous Implanted Port & Catheter (FDA Code: LKG / 882.5550)

• Junior Tongue Depressor (FDA Code: FMA / 880.6230)

• Lacrimal Dilator (FDA Code: HNW / 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.

• Lacrimal Probes (FDA Code: HNL / 886.4350)

• Lacrimal Sac Rongeur (FDA Code: HNG / 886.4350)

• Laparoscopic Probes

• Laryngectomy Tube (FDA Code: KAC / 874.4420)

• Laser Power Probe

• Ligature Carrier (FDA Code: GEJ / 878.4800)

• Ligature Carrier Set (FDA Code: GEJ / 878.4800)

• Ligature Passing and Knot Tying Instrument (FDA Code: HCF / 878.4800)

• Light Sources

• Light Sources Advanced Light Source

• Light Sources Alternative Light Source

• Light Sources Creative Light Source

• Light Sources Fiber Optic Light Source

• Light Sources Infrared Light Source

• Light Sources IR Light Source

• Light Sources Led Light Source

• Light Sources Microscope Light Source

• Light Sources Ultra Violet Light Source

• Light Sources UV Light Source

• Light Sources White Light Source

• Light Sources Xenon Light Source

• Low Power Binocular Loupe (FDA Code: HJH / 886.5120) A low-power binocular loupe is a device that consists of two eyepieces, each with a lens or lens system, intended for medical purposes to magnify the appearance of objects.

• Lumbar Intervertebral Fusion Device with Bone Graft (FDA Code: MAX / 888.3080)

• Malleus Nipper (FDA Code: JYR / 874.4420)