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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 hemostasis, ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: aesthetic (dermatology and plastic surgery), gastroenterology, general surgery, genitourinary surgery (urology), gynecology (GYN), neurosurgery, otolaryngology (ENT), ophthalmology, arthroscopy, podiatry, pulmonology, and thoracic surgery; and Laser Assisted Lipolysis (980 nm only). 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: orthopedics. The PhotoMedex LaserPro 810, 940 and 980 Surgical Diode Laser Systems are indicated for use in the performance of specific surgical applications in aesthetic (dermatology and plastic surgery), gastroenterology, general surgery, genitourinary surgery (urology), gynecology (GYN), neurosurgery, otolaryngology (ENT), ophthalmology, orthopedics, arthroscopy, podiatry, pulmonology, and thoracic surgery; and Laser Assisted Lipolysis (980 nm only) as follow: Gastroenterology The hemostasis, 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. - = hemostasis of upper and lower GI bleeding (810 nm or 980 nm only); - excision and vaporization of colorectal carcinoma (810 nm or 980 nm only); - .. excision of polyps (810 nm or 980 nm only). Neurosurgery The hemostasis, ablation, vaporization, excision, and coagulation of soft tissue in neurosurgery procedures. Applications include: - tumors adjacent to the spinal cord; - tumors adjacent to the cortex. General Surgery, Aesthetic (Dermatology and Plastic Surgery), and Podiatry Treatment of varicose veins and varicosities associated with superficial reflux of the great saphenous vein. The hemostasis, ablation, vaporization, excision, and coagulation of soft tissue in general surgery including endoscopic and open procedures. Applications include: - Laparoscopic - appendectomy; - - cholecystectomy; - - bowel resection. - Open - mastectomy; ・ - reduction mammoplasty; ー - breast biopsy; - rectal and anal hemorrhoidectomy; - - bowel resection; - - ー colectomy: - cholecystectomy; " - liver resection: - - condyloma: - thyroidectomy; - - thoracotomy; - - cavernous hemangioma; - Open (810 nm or 980 nm only) - matrixectomy; - - excision of neuromas; - excision of perifungual & subungual warts; - - excision of plantar warts; - - excision of keloids - - excision of cutaneous lesions; - - debridement of decubitus ulcer; - - hepatobillary tumors; - - dermabrasion; - - vaporization & hemostasis of capillary hemangioma; - - excision, vaporization, & hemostasis of abdominal turnors; - excision, vaporization & hemostasis of rectal pathology; - - pilondial cystectomy; - - herniorrhaphy; - - adhesiolysis; - - parathyroidectomy: - - thyroidectomy; । - resection of organs; - - debridement of wounds - photocoagulation of telangiectasia of the legs and face; - photocoagulation of vascular lesions of the face and extremities. Genitourinary (Urology) The hemostasis, ablation, vaporization, excision, incision, and coagulation of soft tissue in genitourinary (urology) procedures. Applications include: - Transurethral - transurethral incision of the prostate (TUP); - - bladder tumors; - bladder neck incisions; - removal of bladder neck obstructions (810 nm or 980 nm only); - - urethral strictures; - exterior sphincterotomy. | - vaporization of urethral tumors (810 nm or 980 nm only). - Laparoscopic - lymphadenectomy. ー - -Open - condyloma; - - circumcision - - benign and malignant lesions of external genitalia. Thoracic Surgery The hemostasis, 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; ﮯ - adhesiolysis; - - pericardiectomy - - mediastinal and thoracic lesions and abnormalities; - - mediastinal lymph node dissection; - - thoracotomy. - Gynecology (GYN) The hemostasis, 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; 1 - menorrhagia (810 nm or 980 nm only). - 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. 工 Pulmonology The hemostasis, ablation, vaporization, excision, and coagulation of soft tissue in pulmonology procedures. Applications include: - tracheal bronchial lesions. - tracheobronchial malignancy or stricture; (810 nm or 980 nm only) " - benign and malignant pulmonary obstruction; (810 nm or 980 nm only) - endoscopic pulmonary applications. (810 nm or 980 nm only) 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 and arthroscopy; and the hemostasis of soft tissue in arthroscopy. Applications include: - Open - dissect and coagulate. - Otolaryngology (ENT) The hemostasis, 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; ﺖ - hemi glossectomy; … Head & Neck - - tumor resection on oral, subfacial and neck tissues; - - parathyroidectomy; ﺳ - thyroidectomy. - Laser Assisted Lipolysis (980 nm only)

The PhotoMedex LaserPro 810, 940 and 980 Surgical Diode Laser Systems are designed to provide laser power at wavelengths of 810nm, 940nm, and 980nm, 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 K. 040294 and K042211. Differences between the cleared and modified device are limited to: - Addition of Laser Assisted Lipolysis to the indications of use of the LaserPro 980 Surgical Diode Laser Systems previously cleared via K040294 and K042211. - * Addition of several other indications for use to the indications for use of the LaserPro 810, 940 & 980 Surgical Diode Laser Systems previously cleared via K040294 and K042211. 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. .

UVB Phototherapy for psoriasis, vitiligo, atopic dermatitis, and leukoderma

The XTRAC Ultra Excimer Laser System, Model AL10000 is a complete self-contained compact UVB laser light source, which utilizes a XeCl gas mixture to generate an operator selected dose and target-specific ultraviolet light at monochromatic wavelength of 308 nm. The laser system consists of a touch-screen display, an advanced fiberoptic cable attached to a handpiece, and a foot-switch to initiate exposure. The laser is enclosed in a protective interlocked housing. The unit is designed to operate on standard AC power available from wall outlets and can accommodate US, European and other nominal supply voltages and operating frequencies.

The CLARIMEDIX device is indicated for use to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting relaxation of muscle tissue; and to temporarily increase blood circulation where applied.

The system is a self-contained unit with four treatment areas. - . Popliteal treatment zone - Calf treatment zone . - Foot treatment zone . - . Heel treatment zone

UVB phototherapy for skin conditions which include psoriasis, vitiligo, atopic dermatitis, and leukoderma.

The VTRAC Excimer Lamp System is a self-contained non-invasive (non-ablating) system that emits targeted (ultra-narrow) ultraviolet wavelength that is included in the UV-B region of the electromagnetic spectrum centered at 308 mm, which is effective for the treatment of skin conditions that respond favorably to and available UV-B phototherapy. UV-B is emitted from a XeCl excimer lamp inside a handpiece used to apply targeted UVB energy to only areas that require treatment, thus allowing non-involved areas (healthy) of the skin to be spared from exposure.

PharmGuard™ Toolbox is intended to provide a vehicle to create and securely upload user-defined configuration parameters, a library of drug names and associated user-defined infusion parameters to Medex Infusion Pumps. The PharmGuard Toolbox collects and downloads operational, infusion, and alarm history events, library usage counts, and PharmGuard™ safety events from motory overner lardly assomment it is intended to provide a rich dataset users can collect and analyze to improve overall processes and lessen the likelihood of operator error when entering infusion parameters into the Medex Infusion Pumps.

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UVB Phototherapy for psoriasis, vitiligo, atopic dermatitis, and leukoderma

The XTRAC XL2 Excimer Laser System Model AL8000 is a complete self-contained compact UVB laser light source, which utilizes a XeCl gas mixture to generate an operator selected dose and target-specific ultraviolet light at monochromatic operater services ann. The laser system consists of a touch-screen display, an advanced fiberoptic cable attached to a handpiece, and a foot-switch to initiate exposure. The laser is enclosed in a protective interlocked housing. The unit is designed to operate on standard AC power available from wall outlets and can accommodate US, European and other nominal supply voltages and operating frequencies.

The PhotoMedex LaserPro 810, 940 and 980 Surgical Diode Laser Systems, (and the fiber delivery systems and accessories used to deliver laser energy), are intended for delivery of laser light in the contact or non-contact mode during surgical procedures, including via endoscopes, introducers, or catheters. The PhotoMedex LaserPro 810, 940 and 980 Surgical Diode Laser Systems, (and the fiber delivery systems and accessories used to deliver laser energy), are generally indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, hemostasis or coagulation of soft tissue in surgical procedures in medical specialties including: dermatology, gastroenterology, general surgery (including specific treatment of varicose veins and varicosities associated with superficial reflux of the greater saphenous vein), genitourinary surgery (urology), gynecology (GYN), neurosurgery, otolaryngology (ENT), orthopedics, ophthalmology, pulmonology, and thoracic surgery.

The PhotoMedex LaserPro 810. 940 and 980 Diode Laser Systems are designed to provide laser power at wavelengths of 810nm, 940nm, and 980mm, depending on model, which can be used for the procedures indicated in the next section of this summary . 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 Medex 3000 Series MRI Syringe Infusion Pump indications for use are as follows: - in the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids. - in the following delivery routes: arterial, epidural, intravenous, spinal, subcutaneous, and enteral. - in the following delivery modes: continuous, volume/time, mass, body weight, custom dilution, intermittent and bolus. - in critical care, anesthesia, neonatal and pediatric applications or other healthcare settings where the use of the syringe infusion pump can be monitored or supervised by a clinician. - inside the MRI room mounted outside the 150 Gauss line and with shielded magnets of field strength of 1.5 Tesla or less. The syringe infusion pump is contraindicated for use on the inlet side of Extracorporeal Membrane Oxygenation (ECMO) systems where the negative pressure is greater than -100mm Hg as the high negative pressures can result in uncontrolled fluid flow.

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The PhotoMedex LaserPro CO2 Carbon Dioxide Laser System, when used with the delivery accessories identified in the Users Instructions (used to deliver laser energy), is indicated for use in surgical applications requiring the ablation, vaporization, excision, and coagulation of soft tissue in medical specialties including: aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (ENT), gynecology (including laparoscopy), neurosurgery, orthopedics (soft tissue), arthroscopy (knee), general and thoracic surgery (including open and endoscopic), dental and oral surgery and genitourinary surgery. The LaserPro CO2 Surgical Laser is indicated for use in the performance of specific surgical applications in aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (ENT), gynecology (including laparoscopy), neurosurgery, orthopedics (soft tissue), arthroscopy (knee), general and thoracic surgery (including open and endoscopic), dental and oral surgery and genitourinary surgery as follows: Dermatology & Plastic Surgery: The ablation, vaporization, excision, and coagulation of soft tissue in dermatology and plastic surgery in the performance of: Laser skin resurfacing; Laser derm-abrasion; Laser burn debridement. Laser skin resurfacing (ablation and/or vaporization) for treatment of: wrinkles, rhytids, and furrows (including fine lines and texture irregularities). Laser skin resurfacing (ablation and/or vaporization) of soft tissue for the reduction, removal, and/or treatment of: keratoses, including actinic and seborrheic keratosis, seborrhoecae vulgares, seborrheic wart, and verruca seborrheica; vermillionectomy of the lip; cutaneous homs; solar/actinic clastosis; cheilitis, including actinic cheilitis; lentigines, including lentigo maligna or Hutchinson's malignant freckle; uneven pigmentation/ dyschromia; acne scars; surgical scars; keloids including acne keloidalis nuchae; hemangiomas (including Buccal, port wine and pyogenic granulomas/granuloma pyogenicum/granuloma telagiectaticum); tattoos; telangiectasia; removal of small skin tumors, including periungual (Koenen) and subungual fibmromas; superficial pigmented lesions; adenosebaceous hypertrophy or sebaceous hyperplasia; rhinophyma reduction; cutaneous papilloma (skin tags); milia; debridement of eczematous or infected skin; basal and squamous cell carcinoma, including keratoacanthomas, Bowen's disease (Frythroplasia of Queyrat), and Bowenoid Papulosis (BP) lesions; nevi, including spider, epidermal and protruding; neurofibromas; laser de-epithelialization; tricoepitheliomas; xanthelasma palpebrarurn; syringoma. Laser ablation, vaporization and/or excision for complete and partial nail matrixectomy. Vaporization/coagulation of: Benign/malignant vascular/avascular skin lesions; Moh's Surgery; lipectomy; verrucae and seborthoecae vulgares, including paronychial, periungal, and subungual warts. Laser incision and/or excision of soft tissue for the performance of upper and lower eyelid blepharoplasty. Laser incision and/or excision of soft tissue for the creation of recipient sites for hair transplantation. Podiatry: Laser ablation, vaporization and/or excision of soft tissue for the reduction, removal, and/or treatment of: verrucae vulgares/plantar (warts), including paronychial, periungal, and subungual warts; fungal nail treatment; porokeratoma ablation; ingrown nail treatment; neuromas/fibromas, including Morton's neuroma; debridement of ulcers; other soft tissue lesions. Genitourinary: Incision, excision and vaporization of soft tissue in genitourinary procedures. Applications include: benign and malignant lesions of external genitalia; condyloma; phimosis; erythroplasia. Otolaryngology (ENT): Laser incision, excision, ablation and/or vaporization of soft tissue in otolaryngology for treatment of: choana1 atresia; leukoplakia, including oral, larynx, uvula, palatal, upper lateral pharyngeal tissue; nasal obstruction; adult and juvenile papillomatosis polyps; polypectomy of nose and nasal passages; lymphangioma removal; removal of vocal cord/fold nodules, polyps and cysts; removal of recurrent papillomas in the oral cavity, nasal cavity, larynx, pharynx and trachea, including the uvula, palatal, upper lateral pharyngeal tissue, tongue and vocal cords; laser/tumor surgery in the larynx, pharynx, nasal, ear and oral structures and tissue; Zenker's Diverticulum/ pharyngoesophageal diverticulum [endoscopic laser-assisted esophagodiverticulostomy (ELAED)]; stenosis, including subglottic stenosis; tonsillectomy (including tonsillar cryptolysis, neoplasma) and tonsil ablation/tonsillotomy; pulmonary bronchial and tracheal lesion removal; benign and malignant nodules, tumors and fibromas (larynx, pharynx, trachea, tracheobronchial/endobronchia1); benign and malignant lesions and fibromas (nose and nasal passages); benign and malignant tumors and fibromas (oral); stapedotomy/stapedectomy; acoustic neuroma in the ear; superficial lesions of the car, incl. chondrodermatitis nondularis chronica helices/Winkler's disease; telangiectasia/hemangioma of larynx, pharynx and trachea (includes uvula, palatal or upper lateral pharyngeal tissue); cordectomy, cordotomy (for the treatment of vocal fold paralysis/vocal fold motion impairment), and cordal lesions of larynx, pharynx and trachea; myringotomy/tympanostomy (tympanic membrane fenestration); uvulopalatoplasty (LAUP, laser UPPP); turbinectomy and turbinate reduction/ablation; septal spur ablation/reduction and septoplasty; partial glossectomy; tumor resection on oral, subfacial and neck tissues; rhinophyma; verrucae vulgares (warts); gingivoplasty/gingivectomy. Gynecology (GYN): Laser incision, excision, ablation and/or vaporization of soft tissue in gynecology (GYN) for treatment of: 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; leukoplakia (vulvar dystrophies); incision and drainage (I&D) of Bartholin's and nubuthian cysts; herpes vaporization; urethral caruncle vaporization; cervical dysplasia; benign and malignant tumors; hemangiomas. GYN Laparoscopy: Vaporization, incision, excision, ablation, or photocoagulation of soft tissue in endoscopic and laparoscopic surgery, including GYN laparoscopy, for treatment of: endometrial lesions, including ablation of endometriosis; excision/lysis of adhesions; salpingostomy; oophorectomy/ovariectomy; fimbroplasty; metroplasty; microsurgery (tubal); uterine myomas and fibroids; ovarian fibromas and follicle cysts; uterosacral ligament ablation; hysterectomy. Neurosurgery: Laser incision, excision, ablation and/or vaporization of soft tissue in neurosurgery for the treatment of: Cranial: Posterior fossa tumors; peripheral neurectomy; arteriovenous malformation; benign and malignant tumors and cysts [e.g. gliomas, menigiomas (including basal tumors), acoustic neuromas, lipomas and large tumors]; pituitary gland tumors (transsphenoidal approach). Spinal Cord: incision/excision and vaporization of benign and malignant tumors and cysts; Intra- and extradural lesions; laminectomy/ laminotomy/ microdiscectomy. General and Thoracic Surgery: Incision, excision and vaporization of soft tissue in general and thoracic surgery including endoscopic and open procedures. Applications include: debridement of decubitus ulcers, stasis, diabetic and other ulcers; mastectomy; debridement of burns; rectal and anal hemorrhoidectomy; breast biopsy; reduction mammoplasty; cytoreduction for metastatic disease; laparotomy and laparoscopic applications; skin tag vaporization; atheroma; abscesses; other soft tissue applications; mediastinal and thoracic lesions and abnormalities; cysts, including sebaceous cysts, pilar cysts, and mucous cysts of the lips; pilonidal cyst removal and repair. Orthopedics: Incision, excision and vaporization of soft tissue in orthopedic surgery. Applications include: Arthroscopy: menisectomy; chondromalacia; chondroplasty; excision of plica; partial synovectomy; ligament release (lateral and other). General: debridement of traumatic wounds; debridement of decubitus and diabetic ulcers; microsurgery; artificial joint revision; PMMA removal. Dental Oral Surgery: Incision, excision and vaporization of soft tissue in dentistry and oral surgery. Applications include: gingivectomy- removal of hyperplasias; gingivoplasty; incisional and excisional biopsy; frenectomy (frenum release); treatment of ulcerous lesions, including aphthous ulcers; incision of infection when used with antibiotic therapy; excision and ablation of benign and malignant lesions; homcostasis; operculectomy; crown lengthening; removal of soft tissue, cysts and tumors; oral cavity tumors and hemangiomas; abscesses; extraction site hemostasis; salivary gland pathologies; preprosthetic gum preparation; leukoplakia; partial glossectomy; periodontal gum resection.

The PhotoMedex LaserPro CO2 carbon dioxide laser system is designed to provide infrared laser power at a wavelength of 10,600nm which can be used for the procedures indicated in the next section. The system is comprised of the following main components: A laser console, A laser console tower, Display panel with soft-touch keypad control and separate Emergency Off button, Laser system microprocessor control electronics with operating software, A seven segment counterbalanced articulated arm designed to accept the delivery accessories defined in CHART A located in the next section, A detachable covered footswitch.

UVB Phototherapy for psoriasis, vitiligo, atopic dermatitis, and leukoderma

The XTRAC XL Plus Excimer Laser Phototherapy Svstem is a complete self-contained compact UV laser light source, which utilizes a XeCl gas mixture to generate dose-selected and target specific ultraviolet light at wavelength of 308 nm. The laser system consists of a keypad and display, a fiberoptic delivery system, a handpiece and a foot-switch. The laser is enclosed in a protective interlocked housing.