Search Results

The PhotoMedex LaserPro 810, 940 and 980 Surgical Diode Laser Systems, (and the fiber delivery systems and accessories used to deliver laser energy), are indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: gastroenterology, neurosurgery, general surgery, genitourinary (urology), thoracic surgery, gynecology (GYN), pulmonology, ophthalmology, and orthopedics, and otolaryngology (ENT). The PhotoMedex LaserPro 810, 940 and 980 Surgical Diode Laser Systems are indicated for use in the performance of specific surgical applications in gastroenterology, neurosurgery, general surgery, genitourinary (urology), thoracic surgery, gynecology (GYN), pulmonology, ophthalmology, and orthopedics, and otolaryngology (ENT) as follows: Gastroenterology The ablation, vaporization, excision, incision, and coagulation of soft tissue in gastroenterology procedures. Applications include: - hemostasis of esophageal varices; - palliation of malignant dysphagia; - palliative ablation of obstructive neoplasms; - hemostasis of colonoscopy. Neurosurgery The ablation, vaporization, excision, incision, and coagulation of soft tissue in neurosurgery procedures. Applications include: - tumors adjacent to the spinal cord; - tumors adjacent to the cortex. General Surgery Treatment of varicose veins and varicosities associated with superficial reflux of the greater saphenous vein. The ablation, vaporization, incision, and coagulation of soft tissue in general surgery including endoscopic and open procedures. Applications include: - Laparoscopic - appendectomy; - cholecystectomy; - bowel resection. - Open - mastectomy; - reduction mammoplasty; - breast biopsy; - rectal and anal hemorrhoidectomy; - bowel resection; - colectomy; - cholecystectomy; - liver resection; - condyloma; - thyroidectomy; - thoracotomy; - cavernous hemangioma. Genitourinary (Urology) The ablation, vaporization, excision, incision, and coagulation of soft tissue in genitourinary (urology) procedures. Applications include: - Transurethral - transurethral incision of the prostate (TUIP); - bladder tumors; - bladder neck incisions; - urethral strictures; - exterior sphincterotomy. - Laparoscopic - Lymphadenectomy. - Open - condyloma; - circumcision - benign and malignant lesions of external genitalia. Thoracic Surgery The ablation, vaporization, excision, incision, and coagulation of soft tissue in thoracic surgery including endoscopic and open procedures. Applications include: - pulmonary resection; - coagulation of blebs and bullae; - adhesiolysis; - pericardiectomy - mediastinal and thoracic lesions and abnormalities; - mediastinal lymph node dissection; - hemostasis; - thoracotomy. Gynecology (GYN) The ablation, vaporization, excision, incision, and coagulation of soft tissue in gynecology (GYN) procedures. Applications include: - Laparoscopic - excision/lysis of adhesions; - endometrial lesions, including ablation of endometriosis; - laparoscopic assisted hysterectomy (LAVH); - laser uterosacral nerve ablation (LUNA); - myomectomy; - ovarian cystectomy; - ovarian drilling; - tubal fimbrioplasty; - appendectomy. - Open - conization of the cervix, including cervical intraepithelial neoplasia (CIN), vulvar and vaginal intraepithelial neoplasia VIN, VAIN; - Condyloma acuminata, including cervical, genital, vulvar, perineal, and Bowen's disease, (Erythroplasia of Queyrat) and Bowenoid papulosa (BP) lesions. - Intrauterine - Fibroids/polyps/adhesions; - Resection of septum. Pulmonology The ablation, vaporization, excision, incision, and coagulation of soft tissue in pulmonology procedures. Applications include: - tracheal bronchial lesions. Ophthalmology The ablation, vaporization, excision, incision, and coagulation of soft tissue in ophthalmology procedures. Applications include: - Oculoplastics - open DCR; - endo-nasal DCR; - tumor excision and biopsy; - eyelid reconstruction; - blepharoplasty. Orthopedics The ablation, vaporization, excision, incision, and coagulation of soft tissue in orthopedic surgery procedures. Applications include: - Open - Dissect and coagulate. Otolaryngology (ENT) The ablation, vaporization, excision, incision, and coagulation of soft tissue in otolaryngology procedures. Applications include: - Nasal/Sinus - turbinectomy and turbinate reduction/ablation; - polypectomy of nose and nasal passages; - ethmoidectomy; - meatal antrostomy; - Laryngo-tracheal - removal of vocal cord/fold nodules, polyps and cysts; - arytenoidectomy; - tracheal stenosis; - Oropharyngeal - uvulopalatoplasty (LAUP, laser UPPP); - tonsillectomy (including tonsillar cryptolysis, neoplasma) and tonsil; - hemi glossectomy; - Head & Neck - tumor resection on oral, subfacial and neck tissues; - parathyroidectomy; - thyroidectomy.

The PhotoMedex LaserPro 810, 940 and 980 Diode Laser Systems are designed to provide laser power at wavelengths of 810mm, 940mm, and 980mm, depending on model, which can be used for the procedures indicated in the next section of this summary. These devices have been cleared previously via K040294. Differences between the cleared and modified device are limited to: - Maximum output power increased from 20 to 25 Watts (Systems are identified by output frequency and maximum power). - User adjustable (intensity) aiming beam (the maximum aiming beam optical power does not change from currently cleared device). The system is comprised of the following main components: - A laser console/cabinet with fiber port to accept SMA-905 connectors. - Display panel with soft-touch keypad control and separate Emergency Off button. - Laser system microprocessor control electronics with operating software - A detachable covered footswitch.

The SLT Venous Fiber is intended for use in endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux.

SLT Venous FDS products include the Venous Diffusing Fiber, the Venous Conical Fiber, and the Venous Flat Fiber. SLT Venous Diffuser Fibers are flexible fibers with an active diffusing portion that diffuses the laser energy in a uniform pattern about its active diffusing length, resulting in a cylindrical or elongated spheroidal zone of coagulation. SLT Venous Conical Fibers splay the laser energy radially at their distally conical portion, providing a much smaller and more focused coagulation zone than the Venous Diffuser Fiber. SLT Venous Flat Fibers direct the laser energy forward from their distally flat end, providing the highest energy density of the three SLT Venous Fibers. SLT Venous Fibers are available with SLT proprietary connectors (to fit SLT Contact Laser Systems) and SMA-905 connectors (to fit lasers with standard SMA-905 launch interfaces). SLT Venous Diffuser Fibers are compatible for use only with lasers having wavelengths between 980nm and 1064nm. SLT Venous Conical and Flat Fibers are compatible for use with lasers having wavelengths between 810nm and 1064nm. SLT Venous Fibers are flexible and therefore, when used for endovascular applications, a catheter, cannula, or similar device should be used to insert the fiber into the vein. SLT Venous Fiber products are sold sterile, and are intended for single use only.

The SLT bipolar sheath is indicated for use with currently marketed cutter systems used in Orthopedic Surgery. The SLT bipolar sheath is intended to provide coagulation of tissue at the distal end of the cutter tip. This sheath is designed with a standard interface to allow use with most electrosurgical generators. The SLT HemoSleeve Bipolar Sheath is indicated for use in general surgery procedures to provide coagulation at the distal end of a tissue debrider tip.

The SLT bipolar sheath is intended to provide coagulation of tissue at the distal end of the cutter tip. This sheath is designed with a standard interface to allow use with most electrosurgical generators.

The SLT Pneumatic Cutter System is indicated for use in Ear Nose and Throat Surgery primarily sinus endoscopy, and orthopedic procedures primarily arthroscopy. The cutter is intended to achieve the removal of tissue, both soft tissue and bone with the appropriate handpiece. It will also provide suction and irrigation to the operative site. The SLT Pneumatic Cutter System is intended to cut and remove soft tissue. The primary areas of use are Sinus Endoscopy (ENT) and Arthroscopy (Orthopedic) procedures. The tissue is cut with a disposable cutting blade which has an irrigation and suction port designed into its core. The tissue is automatically suctioned away once cut. The device can also drill bone material and automatically remove the bone dust and fragments through an internal suction port.

The SLT Pneumatic Cutter System is intended to cut and remove soft tissue. The primary areas of use are Sinus Endoscopy (ENT) and Arthroscopy (Orthopedic) procedures. The tissue is cut with a disposable cutting blade which has an irrigation and suction port designed into its core. The tissue is automatically suctioned away once cut. The device can also drill bone material and automatically remove the bone dust and fragments through an internal suction port.

The SLT Bipolar Sheath is indicated for use with currently marketed debrider system tips used in Ear Nose and Throat Surgery. The SLT bipolar sheath is intended to provide coagulation of tissue at the distal end of the debrider tip.

The SLT bipolar sheath is indicated for use with currently marketed debrider systems used in Ear Nose and Throat Surgery. The SLT bipolar sheath is intended to provide coagulation of tissue at the distal end of the debrider tip. This sheath is designed with a standard interface to allow use with most electrosurgical generators.

The SLT CL MD Laser Systems are intended to be used in general surgery as well as multiple surgical specialties such as Urology, Gynecology, ENT, Head and Neck, Gastroenterology, Neurosurgery, Thorasic surgery, Pulmonology, Plastic surgery and Orthopedics. The fiber delivery systems achieve the precise tissue effects of incision, excision, vaporization and coagulation of tissue. This device is specifically intended for use in prostate procedures which treat the clinical condition of Benign Prostatic Hyperplasia. This device is currently cleared for market for multiple surgical indications. The specific indication for use of the SLT® Contact Laser™ Fiber Delivery System is for the Incision, Excision, Coagulation and Vaporization of soft tissue for prostatectomy in treatment of Benign Prostatic Hyperplasia (BPH). Vaporization of Prostatic Tissue - The Contact Laser Vaporization of the Prostate (CLVP) procedure vaporizes prostate lobe tissue as well as tissue obstructing the urinary channel. This procedure is indicated for prostates up to 45 grams in size. Coagulation and Vaporization of Prostatic Tissue - The Coagulation and Hemostatic Resection of the Prostate (CHRP)™ coagulates the prostate lobe tissue and vaporizes tissue obstructing the urinary channel. This procedure is indicated for prostates up to 75 grams.

The SLT CL MD Laser Systems are intended to be used in general surgery as well as multiple surgical specialties such as Urology, Gynecology, ENT, Head and Neck, Gastroenterology, Neurosurgery, Thorasic surgery, Pulmonology, Plastic surgery and Orthopedics. The fiber delivery systems achieve the precise tissue effects of incision, excision, vaporization and coagulation of tissue.

The SLT Select Fiber Delivery Systems and Contact Tips are indicated for use in General Surgery as well as multiple surgical specialties such as Urology, Gynecology, ENT, Head and Neck, Gastroenterology, Neurosurgery, Thorasic surgery, Pulmonology, Plastic Surgery and Orthopedics. The fiber delivery systems achieve the precise tissue effects of incision, excision, vaporization and coagulation of tissue. The universal SMA-905 connector allows this family of fiber delivery systems and tips to be used with any laser system meeting the following requirements: Laser must operate at a wavelength between 532 and 1064 nanometers. Laser must operate in Continuous Wave (CW) or Quasi Continuous Wave (Quasi CW) mode. Laser must have a numerical apertures of 0.39 or less Laser must accept the universal SMA-905 connector. Fiber Delivery Systems are cleared for use for the particular indications of the laser system to which they are attached. This device is a prescription device.

The SLT Select Fiber Delivery Systems and Contact Tips are intended to be used in general surgery as well as multiple surgical specialties such as Urology, Gynecology, ENT, Head and Neck, Gastroenterology, Neurosurgery, Thorasic surgery, Pulmonology, Plastic surgery and Orthopedics. The fiber delivery systems and tips achieve the precise tissue effects of incision, excision, vaporization and coagulation of tissue. The universal SMA-905 connector allows this family of fiber delivery systems to be used with any laser system of 532 to 1064 nm wavelength which accepts the SMA-905 connector.

Not Found

The SLT Fumich Probe Guide geometry consists of PVC tubing with an adjustable sleeve being a 2-pronged fork on the distal end and a silicone connector on the proximal end of this tubing. Total length of this is approximately 4 inches. The distal end configuration is designed to slide onto tissue and stabilize this tissue. Laser fiber is threaded through the lumen of this guide with a probe at the end of the fiber for direct contact with tissue. Therefore, this configuration allows the user to know where the tissue and the probe are making contact and facilitates contact of the probe to tissue.