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The Lumenis modified AcuPulse CO2 Laser System. Delivery Devices and Accessories, is indicated for the vaporization. incision, excision, ablation or photocoagulation of soft tissue in the surgical specialties of: ENT, Gynecology, Laparoscopic Surgery including GYN Laparoscopy, Aesthetic Surgery, Dental and Oral Surgery, Neurosurgery, Orthopedics, General Surgery and Podiatry. The intended use of the Lumenis modified AcuPulse CO2 Laser System, Devices and Accessories, is for the performance of specific surgical applications in the surgical specialties of ENT. Gynecology, Laparoscopic Surgery including GYN Laparoscopy, Aesthetic Surgery, Dental and Oral Surgery, Orthopedics, General Surgery and Podiatry as follows: Dermatology The Lumenis modified AcuPulse CO2 Laser System, Delivery Devices and Accessories, is indicated for use in dermatology and plastic surgery for the following applications: - · Ablation, vaporization, excision, incision and coagulation of soft tissue in the performance of: - Laser skin resurfacing - Laser dermabrasion - Laser burn debridement - · Laser skin resurfacing (ablation and/or vaporization) for the 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: - Keratosis, including actinic and sebortheic keratosis, sebortheic wart and verruca sebortheice. - Vermillionectomy of the lip - Cutaneous horns - Solar/actinic elastosis - 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 granuloma pyogenicum/granuloma - telangiectaticum) - Tattoos - Telangiectasia - Removal of small skin tumors, including periungual (Koenen) and subungual fibromas - 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 (Erythroplasia of Queyrat), and Bowenoid Papulosis (BP) lesions - Nevi, including spider, epidermal and protruding - Neurofibromas - Laser de-epithelialization - Tricoepitheliomas - Xanthelasma palpebrarum - Syringoma - · Laser ablation, vaporization, and/or excision for complete and partial nail matrixectomy - · Vaporization or coagulation of: - Benign/malignant vascular/avascular skin lesions - Moh's surgery - Lipectomy - Verrucae and seborrhoecae vulgares, including paronvchial, periungal and subungual warts - · Laser incision and/or excision of soft tissue for the performance of upper evelid bleoharoplasty - · Laser incision and/or excision of soft tissue for the creation of recipient sites for hair transplantation Podiatry The Lumenis modified AcuPulse CO2 Laser System, Delivery Devices and Accessories, is indicated for the following applications: - · 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 Laser ablation, vaporization, and/or excision for complete and partial (nail) matrixectorny Otolaryngology (ENT) The Lumenis modified AcuPulse CO2 Laser System, Delivery Devices and Accessories, is indicated for laser incision, excision, ablation and/or vaporization of soft tissue in otolaryngology for the treatment of: - Choanal atresia - Leukoplakia, including oral, larynx, uvula, palatal, and 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, larvox, pharvnx and traches, including the uyula, 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 - Tonsillectorny (including tonsillar cryptolysis and neoplasma) and tonsil ablation/tonsillotomy - Pulmonary bronchial and tracheal lesion removal - Benign and malignant nodules, tumors and fibromas (larynx, trachea, tracheobronchial/endobronchial) - 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 ear, including chondrodermatitis nodularis chronica helices/Winkler's disease - Telangiectasia/hemangioma of larynx, pharynx and traches (includes uvula, palatal, or upper lateral pharyngeal tissue) - Cordectorny, 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 UPP) - Turbinectomy and turbinate reduction/ablation - Septal spur ablation/reduction and septoplasty - Partial glossectomy - Tumor resection of oral, subfacial and neck tissues - Rhinophyma - Verrucae vulgares (warts) - Gingivoplasty/gingivectomy Gynecology and GYN Laparoscopy Indications The Lumenis modified AcuPulse CO2 Laser System, Delivery Devices and Accessories, is indicated for the following applications: - · Laser incision, excision, ablation and/or vaporization of soft tissue in gynecology for the treatment of: - Conization of the cervix, including cervical intraepithelial neoplasia (CIN), and vulvar and vaginal intraepithelial neoplasia (VIN, VAIN) - Condyloma acuminata, including cervical, genital, vulvar, perineal, and Bowenoid papulosa (BP lesions) - Leukoplakia (vulvar dystrophies) - Incision and drainage (I&D) of Bartholin's and nabothian cysts - Herpes vaporization - Urethral caruncle vaporization - Cervical dysplasia - Benign and malignant tumors - Hemangiomas · Varorization, incision, excision, ablation or photocoagulation of soft tissue in endoscopic and laparoscopic surgery, including gynecological laparoscopy, for the treatment of: - Endometrial lesions, including ablation of endometriosis - Excision/lysis adhesions - Salpingostomy - Oophorectomy - Fimbrioplasty - Metroplasty - Microsurgery (tubal) - Uterine myomas and fibroids - Ovarian fibromas and follicle cysts - Uterosacral ligament ablation - Hysterectomy Neurosurgery Indications The Lumenis modified AcuPulse CO2 Laser System, Delivery Devices and Accessories, is indicated for laser incision, excision, ablation and/or vaporization of soft tissue in neurosurgery for the treatment of: - · Cranial - Posterior fossa tumors - Peripheral neurectomy - Benign and malignant tumors and cysts, for example, gliomas (including basal tumors), acoustic neuromas, lipomas, and large tumors - Arteriovenous malformation - Pituitary gland tumors (transphenoidal approach) - · Spinal cord - Incision/excision and vaporization of benign and malignant tumors and cysts - Intra and extradural lesions - Laminectomy/laminotomy/microdiscectomy Orthopedic Indication The Lumenis modified AcuPulse CO2 Laser System, Delivery Devices and Accessories, is indicated for incision, excision, excision, excision, excision, excision, excision, excis and vaporization of soft tissue in orthopedic surgery, including the following applications: - · Arthroscopy - Meniscectomy - Chondromalacia - Chondroplasty - Ligament release (lateral and other) - Excision of plica - Partial synovectomy - · General - Debridement of traumatic wounds - Debridement of decubitus and diabetic ulcers - Microsurgery - Artificial joint revision - PMMA removal General and Thoracic Surgery The Lumenis modified AcuPulse CO2 Laser System, Delivery Devices and Accessories, is indicated for the 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 - Mediastinal and thoracic lesions and abnormalities - Skin tag vaporization - Atheroma - Cysts, including sebaceous cysts, pilar cysts, and mucous cysts of the lips - Pilonidal cyst removal and repair - Abscesses - Other soft tissue applications Dental and Oral Surgery The Lumenis modified AcuPulse CO2 Laser System. Delivery Devices and Accessories, is indicated for the incision. excision and vaporization of soft tissue in dentistry and oral surgery. Applications include: - Gingivectomy/removal of hyperplasias - Gingivoplasty - Incisional and excisional biopsy - Treatment of ulcerous lesions. including aphthous ulcers - Incision of infection when used with antibiotic therapy - Frenectomy (frenum release) - Excision and ablation of benign and malignant lesions - Homeostasis - 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 Lumenis modified AcuPulse Laser System. Delivery Devices and Accessories when used in conjunction with FemTouch and FemX, is indicated for the vaporization, incision, ablation and coagulation of body soft tissue in medical specialties including aesthetic (dermatology and plastic surgery), podiaty, otolaryngology, neurosurgery, orthopedics, general and thoracic surgery. The use with the scanning unit is indicated for ablative skin resurfacing.

The Lumenis AcuPulse CO2 Laser System is an advanced computer-controlled Carbon Dioxide (CO2) laser system, based on a DC-excited sealed-off CO2 laser tube, that can provide up to 30 or 40 Watts (depending on the configuration) on tissue. The AcuPulse CO2 Laser system consists of the following main functional components: - o a Laser Console with a Free Beam Port, to which an articulated arm is attached - a Footswitch to activate the laser treatment beam and allow the selected lase energy to o be transmitted via the delivery device to the target location - 0 a variety of Free Beam Delivery Devices and accessories. The Free Beam Delivery Devices and accessories include: Endoscopes/Laparoscopy accessories, Handpieces/Tips, Micromanipulators, and Scanners with accessories and adaptors and the FemTouch handpieces. The modified AcuPulse system, similarly to its predicates, the previously cleared AcuPulse System (member of the cleared AcuPulse Family of CO2 Laser Systems, cleared under K180597) and the Previously cleared AcuPulse W system (K201663 and K202428), is operated and controlled via proprietary software embedded in the Main controller, Peripheral controller units and PC. The modified AcuPulse System, with the incorporation of the FemTouch and FemX handpieces, shares the same underlying technology and functionality as its predicates.

The subject Lumenis M22 System has connection capability with the following available treatment handpieces, for multiapplication treatment options. All handpieces are designed for aesthetic and dermatological skin procedure applications, as follows: The Intense Pulsed Light (IPL) handpiece with a spectrum of 400-1200nm (with 10 different filters) is indicated for: - Benign epidermal lesions, including dyschromia, hyperpigmentation, melasma, ephelides (freckles) and tattoos - Cutaneous lesions, including warts, scars and striae - Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, erythema of rosacea, angiomas, poikiloderma of Civatte, leg veins and venous malformations - Removal of unwanted hair from all skin types, and to effect stable long term, or permanent* hair reduction in skin types I-V through selective targeting of melanin in hair follicles - Mild to moderate inflammatory Acne (Acne vulgaris) The Nd:YAG Laser handpiece with a wavelength of 1064 nm (Multi-Spot Nd:YAG) is indicated for: - The coagulation and hemostasis of vascular lesions and soft tissue, including the treatment and clearance of superficial and deep telangiectasias) and reticular veins (0.1 - 4.0 mm. diameter) of the leg - The removal of unwanted hair from all skin types, and to effect stable long term, or permanent* hair reduction in skin types I-V through selective targeting of melanin in hair follicles - The non-ablative treatment of facial wrinkles ResurFX module and handpiece. with wavelength of 1565 nm. is indicated for: - Use in dermatological procedures requiring fractional skin resurfacing and coaqulation of soft tissue The Q-Switched Nd:YAG Laser Handpiece with a wavelength of 1064nm is indicated for: - Removal of dark tattoos - Treatment of pigmented lesions *Note Permanent hair reduction is defined as long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime. The ResurFX System with wavelength of 1565 nm. is indicated for use in dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue.

The subject Lumenis M22 System is a multi-application, multi-technology platform with four (4) available treatment handpieces: - Universal Intense Pulsed Light (IPL) handpiece: - Multi-Spot Nd:YAG laser handpiece; - ResurFX non-ablative laser handpiece; - Q-Switched Nd:YAG laser handpiece. The following accessories are provided with and/or may be purchased independently for each of the four (4) available treatment handpieces of the M22 System: - The Universal IPL handpiece has ten (10) different filters available: Cut-off filters of 515, 560, 590,615, 640, 695 and 755 nm, Notch Filters of 400-600 & 800-1200 nm and 530-650 & 900-1200 nm, and a Narrow band filter of 525-585 nm. Further, the IPL handpiece has three (3) sapphire cool light guides available with sizes of: 15mm x 35mm, 8mm x 15 mm, 6mm diameter. - The Multi-Spot Nd:YAG handpiece has four (4) different light guides/tips available in sizes of: 2mm x 4mm, 6 mm, 9 mm and 1.5 mm. - The ResurFX handpiece has two (2) different treatment tips available: SapphireCool and Precision tips. - The Q-Switched Nd: YAG handpiece has both disposable and gold plated metal treatment tips available. The disposable treatment tips are available in four (4) different sizes of: 2, 2.5, 3.5, and 5 mm. The metal treatment tips are available in seven (7) different sizes of: 2, 2.5, 3.5, 4, 5, 6 and 8 mm. The ResurFX System is an advanced computer-controlled laser emission system operating at a wavelength of 1565 nm, and is intended for Fractional Non-Ablative Skin Resurfacing application when using a dedicated handpiece. The following accessories are provided with and/or may be purchased independently for the ResurFX System: - Two (2) different treatment tips: SapphireCool and Precision tips. - Footswitch.

The 1565nm ResurFX laser module is indicated for use in dermatological procedures requiring skin resurfacing and coagulation of soft tissue

The ResurFX module is a 1565nm non ablative laser module that is an add-on to FDA cleared mainframes like the M22 (LUM 2, cleared under K083733). The ResurFX module is constructed of: 1565nm fiber laser Scanner and scanner controller Power Supply Cooling unit Treatment handpiece The system may be activated by either handpiece or footswitch trigger.

The FiberLase CO2 Laser WaveGuide is intended for use in surgical procedures requiring ablation, vaporization, excision, incision and coagulation of soft tissue. The FiberLase CO2 Laser WaveGuide is indicated for use in open surgical procedures such as ENT surgery and laparoscopy and endoscopic procedures. The device is limited to carbon dioxide lasers having a SMA-905 connector.

The CO2 Laser WaveGuide is a laser delivery system for use in surgical procedures requiring ablation, vaporization, excision, incision and coagulation of soft tissue. The CO2 Laser WaveGuide device is indicated for use in open surgical procedures such as ENT surgery and laparoscopy and endoscopic procedures. The CO2 Laser WaveGuide is a hollow, semi-rigid, light-conducting tube designed to operate at wavelengths of 10.6 um and 0.6328 um. These wavelengths correspond to the output of the CO2 laser device and the helium-neon laser aiming beam, thereby allowing both laser radiations to be simultaneously and efficiently transmitted through the same channel. Laser energy entering the waveguide travels down the tube by multiple bounces off the inner reflective surface, and is delivered to the tissue at the distal end. The CO2 Laser WaveGuide is compatible for use with any laser system that has a 905 SMA connector. The WaveGuide is supplied in several configurations with the dimensions specified in the following table: | Core diameter [µm] | Outer diameters [µm] | Lengths [cm] | |--------------------|----------------------|-------------------| | 300 | 700, 800 | 60, 100, 150 | | 500 | 900, 1040 | 60, 100, 150, 200 | | 750 | 1200, 1400 | 100, 150, 200 | Table 1 - CO2 Laser WaveGuide Dimensions The CO2 Laser WaveGuide is supplied with a set of eight hand pieces through which the WaveGuide may be inserted for easy handling in surgical procedures. The hand pieces are available with various features at the distal end to provide angled beam deflection with a highly polished metal surface. The WaveGuide is also provided with cleaving and cutting tools. The WaveGuide accessories are all provided as reusable tools. The CO2 Laser WaveGuide may be used with a gas purge system providing a flow of air of 2 liters per minute and a regulator pressure of 4.5 psi. The gas purge system keeps the inner channel of the waveguide free of debris. The gas purge system is not supplied with the waveguide.

The Lume 2, with Intense Pulsed Light ( IPL) wavelengths 515-1200 nm, is indicated for the treatment of: Benign epidermal lesions, including dyschromia, hyperpigmentation, melasma, ephelides (freckles) and tattoos. Cutaneous lesions, including warts, scars and striae. Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations, and For the removal of unwanted hair from all skin types, an to effect stable long term, or permanent' hair reduction in skin types I-V through selective targeting of melanin in hair follicles. with Nd:YAG laser at wavelength 1064 nm, is indicated for: The coagulation and hemostasis of vascular lesions and soft tissue, including the treatment and clearance of superficial and deep telangiectasias) and reticular veins (0.1-4.0 mm. diameter) of the leg The removal of unwanted hair from all skin types, an to effect stable long term, or permanent' hair reduction in skin types I-V through selective targeting of melanin in hair follicles. The non-ablative treatment of facial wrinkles. 1 Permanent hair reduction is defined as a long-term stable reduction in the number of hairs re-growing after a treatment regimen.

The Lume 2 system is a multi-functional platform, computer controlled system which incorporates two technologies and two treatment heads: Intense Pulsed Light (IPL), and Nd:YAG Laser. The Lume 2 console has a single treatment head connection port that accommodates either the Universal IPL or the Multi-Spot Nd: YAG treatment head. The treatment heads are attached to the head connector via a flexible cable (umbilical). During operation, deionized water circulates from the system console through the umbilical cable to the treatment heads to cool the flashlamp assembly and/ or the laser head, and the umbilical cable also houses the power cable to provide energy to the light/laser emission and the electrical wiring to power the thermoelectric (TE) cooler. The energy is delivered in pulse sequences, to allow better control. The principles of operation and fundamental scientific technology are the same for the subject devices and predicate device.

The Q-switched Nd: YAG Laser Treatment Head for the Quantum series is intended for use in the medical specialties of plastic surgery and dermatology for applications requiring selective photothermolysis and photo-acoustic effects in target chromophores. The Q-switched Nd: YAG Laser Treatment Head for the Quantum series is indicated for: - Removal of dark tattoos - Treatment of pigmented lesions

The Lumenis Quantum series of IPL/Nd: YAG systems are intense pulsed-light (IPL) and Nd: Y AG laser devices. Each Quantum system is comprised of three main components: - A system console (including software and control electronics, key-operated power control switch, power-on indicator, emergency shut-off knob and a remote interlock connector); - A control and display panel; - One or more delivery handpiece(s), the Treatment Heads. The Q-switched Nd: Y AG Treatment Head for the Quantum series is a pulsed laser operating at a wavelength of 1064 nanometers. It is an upgrade that can be installed on any Quantum system. The Q-switched Nd: YAG Laser Treatment Head is a hand held device comprised of the laser head and optics, trigger circuit, safety components and cooling circuit. The Qswitched Nd: YAG Laser Treatment Head is connected to the Quantum console via an umbilical cable and connector.

The Lumenis Family of Disposable Contact Tip Delivery Devices for CO2 Lasers is indicated for use in surgical applications requiring ablation, vaporization, excision, incision, and coagulation of soft tissue using laser-generated thermal energy in medical including aesthetic (dermatology and plastic surgery), podiatry, specialties, 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, for the indications for use that the compatible laser system to which attached has been cleared.

Lumenis Family of Disposable Contact Tip Delivery Devices for CO2 Lasers is comprised of the following main components: - Laser waveguide - Specially-shaped tip - Coupler connector

The Lumenis Family of Intense Pulsed-Light (IPL) and IPL/ Nd: YAG laser systems (and the delivery accessories that are used with them to deliver light and/ or laser energy) are indicated for use in surgical, aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery, and dermatology as follows: Intense Pulsed Light Energy/Wavelengths (515 - 1200 nm) are indicated for: - The treatment of tattoos and benign pigmented epidermal and cutaneous lesions including warts, scars and striae; - The treatment of benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, melsma, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations; - The removal of unwanted hair from all skin types, and to effect stable long-term, or permanent, hair reduction in skin types I-V through selective targeting of melanin in hair follicles. Nd:YAG Laser Wavelength (1064 nm) is indicated for the coagulation and hemostasis of vascular lesions and soft tissue, including: - Treatment and clearance of superficial and deep telangiectasias (venulectasias) and reticular veins (0.1 - 4.0 mm diameter) of the leg. - The removal of unwanted hair from all skin types, and to effect stable long-term, or permanent, hair reduction in skin types I-V through selective targeting of melanin in hair follicles. The Real Time Chiller is indicated for use in cooling the epidermis at the treatment site prior to, during and after light or laser treatment in general surgery, plastic surgery and dermatology to: - Reduce pain during and/or associated with light or laser treatment (via partial anesthesia from cooling); - Reduce discomfort during and/or associated with light or laser treatment; - Minimize thermal injury, including thermal necrosis, to non-target skin and skin structures during and/or associated with light or laser treatment, thus reducing possible complications such as scabbing, scarring, hyper and/or hypopigmentation; - Allow the use of higher light or laser fluences for light or laser treatments (such as for hair removal and the treatment of vascular or pigmented lesions); and - Reduce potential side effects of light or laser treatments (such as for hair removal and the treatment of vascular or pigmented lesions).

Lumenis Family of Intense Pulsed-Light (IPL) and IPL/ Nd:YAG laser systems are comprised of the following main components: - A light/laser system console (including software and control electronics); - A control and display panel; - One or two attached hand-piece(s), which may have integrated skin cooling components.

The Lumenis Family of Intense Pulsed-Light (IPL) systems and combination IPL/Nd:YAG laser systems (and the delivery accessories that are used with them to deliver light and/or laser energy) are indicated for use in surgical, aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery, and dermatology as follows: Intense Pulsed Light Energy / Wavelengths (515 - 1200 nm): - The treatment of tattoos and benign pigmented epidermal and cutaneous lesions * including warts, scars and striae; - * The treatment of benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, melasma, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations; - * The removal of unwanted hair from all skin types, and to effect stable long-term, or permanent1, hair reduction in skin types I-VI through selective targeting of melanin in hair follicles; Nd:YAG Laser Wavelength (1064 nm): - * The coagulation and hemostasis of vascular lesions and soft tissue, including: - * Treatment and clearance of superficial and deep telangiectasias (venulectasias) and reticular veins (0.1 - 4.0 mm diameter) of the leg; - * The non-ablative treatment of facial wrinkles. The Real Time Chiller is indicated for use in cooling the epidermis at the treatment site prior to, during and after light or laser treatment in general surgery, plastic surgery and dermatology to: - * Reduce pain during and/or associated with light or laser treatment (via partial anesthesia from cooling); - Reduce discomfort during and/or associated with light or laser treatment; * - * Minimize thermal injury, including thermal necrosis, to non-target skin and skin structures during and/or associated with light or laser treatment, thus reducing possible complications such as scabbing, scarring, hyperand/or hypopigmentation; - * Allow the use of higher light or laser fluences for light or laser treatments (such as for hair removal and the treatment of vascular or pigmented lesions); and - * Reduce potential side effects of light or laser treatments (such as for hair removal and the treatment of vascular or pigmented lesions).

Lumenis Family of Intense Pulsed-Light (IPL) and IPL/Nd:YAG laser systems are comprised of the following main components: - * A light/laser system console (including software and control electronics); - A control and display panel; and * - * One or more attached hand-piece(s), which may have integrated skin cooling components.

The Modified Lumenis Family of UltraPulse SurgiTouch CO2 Surgical Lasers (and the delivery accessories that are used with them to deliver laser energy) are indicated for use in surgical applications requiring the ablation, vaporization, incision, 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 Modified Lumenis Family of UltraPulse Surgical Lasers are 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, incision, 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). Clinical study demonstrated that skin resurfacing of wrinkles, rhytids, and furrows with the UltraPulse CO2 laser increases the amount of sub-epidermal collagen. 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 horns; solar/actinic elastosis; 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 fibromas; 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 (Erythroplasia of Queyrat), and Bowenoid Papulosis (BP) lesions; nevi, including spider, epidermal and protruding; neurofibromas; laser de-epithelialization; tricoepitheliomas; xanthelasma palpebrarum; 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 seborrhoecae 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. Laser ablation, vaporization and/or excision in podiatry for complete and partial matrixectomy. Otolaryngology (ENT): Laser incision, excision, ablation and/or vaporization of soft tissue in otolaryngology for treatment of: choanal 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 fendoscopic 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/endobronchial); 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 ear, including 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; benign and malignant tumors and cysts (e.g. gliomas, menigiomas (including basal tumors), acoustic neuromas, lipomas and large tumors); arteriovenous malformation; pituitary gland tumors (transphenoidal approach). Spinal Cord: incision/excision and vaporization of benign and malignant tumors and cysts; intra- and extradural lesions; laminectomy/ laminotomy/ microdiscectomy. Orthopedics: Incision/excision and vaporization of soft tissue in orthopedic surgery. Applications include: Arthroscopy: menisectomy; chondromalacia: chondroplasty; ligament release (lateral and other); excision of plica; partial synovectomy. General: debridement of traumatic wounds; debridement of dualifatio woulds; debridement of decubitus and diabetic ulcers; and New; microsurgery; artificial joint revision; PMMA removal. General/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; mediastinal and thoracic lesions and abnormalities; skin tag vaporization; atheroma; cysts, including sebaceous cysts, pilar cysts, and mucous cysts of the lips; pilonidal cyst removal and repair; abscesses; other soft tissue applications. 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; treatment of ulcerous lesions, including aphthous ulcers; incision of infection when used with antibiotic therapy; frenectomy (frenum release); excision and ablation of benign and malignant lesions; homeostasis; 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. Genitourinary: Incision/excision and vaporization of soft tissue in genitourinary procedures. Applications include: benign and malignant lesions of external genitalia; condyloma; phimosis; erythroplasia.

The modified Lumenis family of UltraPulse SurgiTouch CO2 Laser Systems are comprised of the following main components: A laser console. A laser console tower. A counterbalanced articulated arm and delivery system. Control and display panel. System microprocessor control electronics. A covered footswitch or handswitch for specific delivery device accessories. An optional air purge pump system with an insufflator filter for purge of delivery device accessories. Operating software. A variety of delivery device accessories or handpieces, including a pattern generator.