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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• Non-Coherent Light Sources

• Non-Coherent Light Sources For Confocal Microscopy

• Non-Electric Biopsy Forceps (FDA Code: FCL / 876.1075) A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

• Non-Illuminated Speculum (FDA Code: FXE / 878.1800) A speculum is a device intended to be inserted into a body cavity to aid observation. It is either nonilluminated or illuminated and may have various accessories.

• Non-Powered Dynamometer (FDA Code: HRW / 888.1250) A nonpowered dynamometer is a mechanical device intended for medical purposes to measure the pinch and grip muscle strength of a patient's hand.

• Non-Powered Goniometer (FDA Code: KQW / 888.1520) A nonpowered goniometer is a mechanical device intended for medical purposes to measure the range of motion of joints.

• Non-Powered Portable Single Patient Suction Apparatus (FDA Code: GCY / 878.4680) A nonpowered, single patient, portable suction apparatus is a device that consists of a manually operated plastic, disposable evacuation system intended to provide a vacuum for suction drainage of surgical wounds.

• Non-Powered Rectal Probe (FDA Code: EXX / 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.

• Non-Powered Surgical Instrument (FDA Code: HAO / 882.4535) A nonpowered neurosurgical instrument is a hand instrument or an accessory to a hand instrument used during neurosurgical procedures to cut, hold, or manipulate tissue. It includes specialized chisels, osteotomes, curettes, dissectors, elevators, forceps, gouges, hooks, surgical knives, rasps, scissors, separators, spatulas, spoons, blades, blade holders, blade breakers, probes, etc.

• Non-Self-Retaining Retractor (FDA Code: FGN / 876.4730)

• Non-Sterile Ent Cutting Block (FDA Code: NNR / 874.3540) A prosthesis modification instrument for ossicular replacement surgery is a device intended for use by a surgeon to construct ossicular replacements. This generic type of device includes the ear, nose, and throat cutting block; wire crimper, wire bending die; wire closure forceps; piston cutting jib; gelfoamTMpunch; wire cutting scissors; and ossicular finger vise.

• Non-Sterile External Non-Inflatable Extremity Splint (FDA Code: NOC / 878.3910) A noninflatable extremity splint is a device intended to immobilize a limb or an extremity. It is not inflatable.

• Non-Surgical 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.

• Nonresorbable Gauze/sponge for External Use (FDA Code: NAB / 878.4014) A nonresorbable gauze/sponge for external use is a sterile or nonsterile device intended for medical purposes, such as to be placed directly on a patient's wound to absorb exudate. It consists of a strip, piece, or pad made from open woven or nonwoven mesh cotton cellulose or a simple chemical derivative of cellulose. This classification does not include a nonresorbable gauze/sponge for external use that contains added drugs such as antimicrobial agents, added biologics such as growth factors, or is composed of materials derived from animal sources.

• Obstetrical Forceps (FDA Code: HDA / 884.4400) An obstetric forceps is a device consisting of two blades, with handles, designed to grasp and apply traction to the fetal head in the birth passage and facilitate delivery.

• Occlusive Wound Dressing (FDA Code: NAD / 878.4020) An occlusive wound dressing is a nonresorbable, sterile or non-sterile device intended to cover a wound, to provide or support a moist wound environment, and to allow the exchange of gases such as oxygen and water vapor through the device. It consists of a piece of synthetic polymeric material, such as polyurethane, with or without an adhesive backing. This classification does not include an occlusive wound dressing that contains added drugs such as antimicrobial agents, added biologics such as growth factors, or is composed of materials derived from animal sources.

• 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.

• One-Piece Scalpel (FDA Code: GDX / 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.

• Operating Room Scrub Brush (FDA Code: GEC / 878.4800)

• Operating-Room Electrical Table (FDA Code: GDC / 878.4960) Operating tables and accessories and operating chairs and accessories are AC-powered or air-powered devices, usually with movable components, intended for use during diagnostic examinations or surgical procedures to support and position a patient.

• Ophthalmic Aspiration Cannula (FDA Code: HMX / 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.

• Ophthalmic Caliper (FDA Code: HOE / 886.4350)

• Ophthalmic Cannula (FDA Code: HMX / 886.4350)

• Ophthalmic Curette (FDA Code: HNZ / 886.4350)

• Ophthalmic Eye Shield (FDA Code: HOY / 886.4750) An ophthalmic eye shield is a device that consists of a plastic or aluminum eye covering intended to protect the eye or retain dressing materials in place.

• Ophthalmic Forceps (FDA Code: HNR / 886.4350)

• Ophthalmic Hook (FDA Code: HNQ / 886.4350)

• Ophthalmic Knife (FDA Code: HNN / 886.4350)

• Ophthalmic Manual Trephine (FDA Code: HRH / 886.4350)

• Ophthalmic Muscle Clamp (FDA Code: HOB / 886.4350)

• Ophthalmic Operating Spectacle (FDA Code: HOH / 886.4770) Ophthalmic operating spectacles (loupes) are devices that consist of convex lenses or lens systems intended to be worn by a surgeon to magnify the surgical site during ophthalmic surgery.

• Ophthalmic Retractor (FDA Code: HNI / 886.4350)

• Ophthalmic Ring (FDA Code: HNH / 886.4350)

• Ophthalmic Spatula (FDA Code: HND / 886.4350)

• Ophthalmic Speculum (FDA Code: HNC / 886.4350)

• Ophthalmic Spoon (FDA Code: HNB / 886.4350)

• Ophthalmic Spud (FDA Code: HNA / 886.4350)

• Ophthalmic Suture Scissors (FDA Code: HNF / 886.4350)

• Ophthalmic Suturring Needle (FDA Code: HNM / 886.4350)

• Oral Screw (FDA Code: KBW / 874.4420)

• Orbital Depressor (FDA Code: HNX / 886.4350)

• Orthopedic Burr (FDA Code: HTT / 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.

• Orthopedic Cutting Instrument (FDA Code: HTZ / 878.4800)

• Orthopedic Elevator (FDA Code: HTE / 878.4800)

• Orthopedic Knife (FDA Code: HTS / 888.4540)

• Orthopedic Manual Surgical Instrument (FDA Code: LXH / 888.4540)

• Orthopedic Needle Holder (FDA Code: HXK / 888.4540)

• Orthopedic Spatula (FDA Code: HXR / 878.4800)

• Orthopedic Wire Passer (FDA Code: HXI / 888.4540)

• Osteoinduction Bone Void Filler (FDA Code: MBP / 888.3045) A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.