Profile: Laserscope focuses on pelvic health. We offer solutions for men and women in the areas of urinary incontinence, fecal incontinence, vaginal prolapse treatment, uterine health, erectile restoration, and urethral stricture. Some of our product names are Straight-In™ system, Acticon® neosphincter, and UroLume® urethral stent. The Straight-In&trader; system is a secure approach for repairing vaginal vault prolapse, a condition that occurs when the uppermost part of the vagina descends into the vaginal canal or outside the vagina. It is designed to restore normal anatomical positioning. One end of a strip of mesh material is attached to the vaginal apex, and the other end to the sacrum. This mesh support system is designed to return the vaginal axis to a more normal anatomical position. It may be performed using either an open or laparoscopic procedure. The UroLume® urethral stent is an implantable device for men, and is intended to relieve urinary obstruction. It immediately improves the flow of urine, becomes fully incorporated within the body, and allows normal erection without retrograde ejaculation. It does not interfere with serum prostate specific antigen levels, and the procedure can be done under local anesthesia.

The company was founded in 1984, has revenues of USD 100-500 Million, has ~120 employees and is ISO 9001, CE certified. NASDAQ:LSCP (SEC Filings)

FDA Registration Number: 2937094

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• Abdominal Trocar

• AC-Powered Endoscope and Accessories (FDA Code: GCP / 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.

• AC-Powered Operating Headlamp (FDA Code: HPQ / 886.4335) An operating headlamp is an AC-powered or battery-powered device intended to be worn on the user's head to provide a light source to aid visualization during surgical, diagnostic, or therapeutic procedures.

• AC-Powered Operating Room Table (FDA Code: FQO / 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.

• Atraumatic Grasping Forceps

• Bone Fixation Screw (FDA Code: HWC / 888.3040) A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

• C02 Skin Resurfacing Laser Systems

• Compressor Mechanical Cardiac Resuscitator

• Cosmetic Lasers

• Cosmetic Lasers, Contact/non contact mode

• Cosmetic Surgery, Hair Removal Lasers

• Cutaneous Flaws Lasers

• Dermatological Equipment

• Dye Laser

• Endometrial Thermal Ablation Device (FDA Code: MNB)

• Endoscope Video Monitor

• Endoscopic Forceps

• Endoscopic Photographic Accessories (FDA Code: FEM / 876.1500)

• Fiberoptic Illuminator for Endoscope (FDA Code: FFS / 876.1500)

• General Purpose Electrosurgical Equipment

• General Surgical Manual Instrument (FDA Code: MDM / 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.

• Hair Removal Device

• Hair Removal Kits

• Hysteroscopic Insufflator (FDA Code: HIG / 884.1700) A hysteroscopic insufflator is a device designed to distend the uterus by filling the uterine cavity with a liquid or gas to facilitate viewing with a hysteroscope.

• Implanted Fecal Incontinence Device (FDA Code: MIP)

• Inflatable Penis Prosthesis (FDA Code: JCW / 876.3350) A penile inflatable implant is a device that consists of two inflatable cylinders implanted in the penis, connected to a reservoir filled with radiopaque fluid implanted in the abdomen, and a subcutaneous manual pump implanted in the scrotum. When the cylinders are inflated, they provide rigidity to the penis. This device is used in the treatment of erectile impotence.

• Laparoscopic Insufflation Needle

• Laparoscopy Laser Equipment

• Laparoscopy Scissors with Removable Tips

• Lesion Lasers

• Manual Gastro-Urology Surgical Instrument (FDA Code: KOA / 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.

• Mechanical/Hydraulic Impotence Device (FDA Code: FHW / 876.3350)

• Mechanical/Hydraulic Incontinence Device (FDA Code: EZY / 876.5280) An implanted mechanical/hydraulic urinary continence device is a device used to treat urinary incontinence by the application of continuous or intermittent pressure to occlude the urethra. The totally implanted device may consist of a static pressure pad, or a system with a container of radiopaque fluid in the abdomen and a manual pump and valve under the skin surface that is connected by tubing to an adjustable pressure pad or to a cuff around the urethra. The fluid is pumped as needed from the container to inflate the pad or cuff to pass on the urethra.

• Microsurgical Instruments (FDA Code: GZX / 882.4525) A microsurgical instrument is a nonpowered surgical instrument used in neurological microsurgery procedures.

• Microwave Hyperthermia System (FDA Code: MEQ)

• Multi-Image Video Camera

• Multi-Use Electrocauterization Probe

• Operating Room Lamp (FDA Code: FQP / 878.4580) A surgical lamp (including a fixture) is a device intended to be used to provide visible illumination of the surgical field or the patient.

• Penile Prosthesis (FDA Code: FAE / 876.3630) A penile rigidity implant is a device that consists of a pair of semi-rigid rods implanted in the corpora cavernosa of the penis to provide rigidity. It is intended to be used in men diagnosed as having erectile dysfunction.

• Permanent External Sphincter Urethral Stent (FDA Code: MXQ)

• Permanent Or Semi-Permanent Bulbous Urethral Stent (FDA Code: MES)

• Permanent Or Semi-Permanent Prostatic Urethral Stent (FDA Code: MER)

• Polyester Synthetic Non-Absorbable Suture (FDA Code: GAS / 878.5000) Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached.

• Polyethylene Synthetic Non-Absorbable Suture (FDA Code: GAT / 878.5000)

• Polymeric Surgical Mesh (FDA Code: FTL / 878.3300) Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.

• Powered Surgical Laser Instrument (FDA Code: GEX / 878.4810) (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.

• Rigid Endoscope Tester

• Rigid Endoscopes (FDA Code: GCM / 876.1500)

• Single-Use Electrocauterization Probe

• Skin Resurfacing Lasers