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The Lumenis® Smart532™ Laser System is indicated for use in Ophthalmic Applications; Ear, Nose and Throat Applications; Dentistry; and Dermatologic Applications as follows: Ophthalmology Diabetic Retinopathy including Macular Edema or Proliferative Retinopathy Proliferative Diabetic Retinopathy (PDR) Retinal Tear Macular Edema or Proliferative Retinopathy associated with Central Retinal Vein Occlusion (CRVO) or Branch Retinal Vein Occlusion (BRVO) Choroidal Neovascularization (CNV) secondary to Age-related Macular Degeneration (AMD) Central Serous Chorioretinopathy (CSCR) Trabeculoplasty for Primary Open Angle Glaucoma (POAG) Iridotomy / Iridoplasty for Angle-Closure Glaucoma (ACG) Ear, Nose and Throat (ENT) Stapedectomy Stapedotomy Myringotomies Lysis of Adhesions Control of Bleeding Removal of Acoustic Neuromas Soft Tissue Adhesion in Micro/Macro Otologic procedures Dermatology Pigmented lesion, including soar lentigine Vascular lesions, including cherry hemangiomas and angiokeratomas Extremeties telangiectases, including facial and leg telangiectases Cutaneous lesions Flat warts Dermatosis Papulosa Nigra Dentistry Frenectomy Treatment of oral mucous cyst Treatment of benign vascular lesions: Capillary hemangioma Hemorrhagic hereditary telangiectasia Capillary/cavernous hemangiomas Lymphangioma AV malformation of the tongue Hermaniolymphangiomas Photocoagulation of superficial vessels Vaporization of superficial blood or lymph containing vessels Treatment of superficial tongue lesions Tissue management and hemostasis for crown and bridge impressions Incision and drainage for abscess Gingivoplasty/Gingivectomy: Operative procedures Crown and bridge, gingival reduction Crown lengthening Hyperplasia (Drug, irritation, Epulus, ... ) Hemostasis during dental procedures Operculectomy (Operculotomy) Excisional biopsy Free Ginvical Graft (Adjunct): Hemostasis of donor site Hemostasis of graft site Vestibuloplasty Soften Gutta Percha Treatment of canker sores, herpetic lesions, and aphthous ulcers Laser-assisted bleaching/whitening

The subject Lumenis® Smart532™ Laser System product is a dual port, solid state, frequency doubled, green Nd:GdVO4 surgical laser instrument used in the photothermolysis (photocoagulation) of soft tissue at an operating emission wavelength of 532nm, a wavelength that has been used widely and effectively in the market for procedures in the fields of ophthalmology, ENT (ear, nose & throat), dermatology and dentistry. Compatible delivery devices & accessories for use with the subject Lumenis® Smart532™ Laser System include: Slit lamps, Slit lamp adapters/attachments, Laser Indirect Ophthalmoscopes (LIO), Eye safety filters, Laser links, Array LaserLink, Selecta Trio, Fibers and Endo-ocular and Endo-Oto probes. The device software may be adjusted by Lumenis to fit customer needs within the system overall range of parameters.

The Lumenis® Array™ LaserLink™ device is a laser system accessory intended for use in the treatment of ocular pathology. - For the posterior segment, the Lumenis® Array™ LaserLink™ device is indicated for use in retinal photocoagulation and panretinal photocoagulation of vascular and structural abnormalities of the retina and choroid including: - Proliferative and severe and very severe nonproliferative diabetic retinopathy - Macular edema associated with proliferative or nonproliferative diabetic retinopathy - Choroidal neovascularization - Retinal neovascularization associated with retinal occlusive disease (Branch retinal vein occlusion; Central retinal vein occlusion) - Macular edema associated with Branch retinal vein occlusion - Retinal tears and detachments - And anterior segments as follows: - Iridotomy in closed angle glaucoma - Trabeculoplasty in open angle glaucoma

The Lumenis® Array™ LaserLink™ device is a delivery system that adapts an examination slit lamp for use as a therapeutic laser delivery system, utilizing a scanning pattern generator to deliver predefined patterns of treatment. The Lumenis® Array™ LaserLink™ device is comprised of the following components: - ArrayTM LaserLink™M module . - . Console - . Touchscreen display - Remote touchpad . The Array™ LaserLink™ module attaches to the slit lamp and delivers the treatment beam to the target tissue. The console houses the control electronics and power supply, and integrates the Array™ LaserLinkTM module with the laser system. The touchscreen display is used to adjust laser treatment settings, such as laser mode, energy, and aiming beam intensity. It can be positioned on either side of the slit lamp, and duplicates the functions of the laser's remote control. The touchpad is used to micromanipulate the position of the aiming and treatment beams, adjust laser power, spot size, the number of spots, and pattern parameters.

The VersaPulse P20 Laser System is intended for use in surgical procedures requiring open, laparoscopic and endoscopic ablation, vaporization, excision, incision, and coagulation of soft tissue. The VersaPulse P20 Ho:YAG (2.1 μm wavelength) is indicated for use in surgical procedures involving open, laparoscopic and endoscopic ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: Arthroscopy, Urinary lithotripsy, Gynecological surgery, Gastroenterological surgery, Urology, ENT surgery, General surgery

The VersaPulse P20 Laser System is a desktop 20 Watt surgical Holmium laser and is an improved model configuration of the 20 Watt VersaPulse PowerSuite Holmium Surgical Laser, [510 (k) K011703]. Main functional components : - A Laser console . - . Control and display panel - A fiber port for Laser delivery systems - . A covered foot switch - Operating software - A variety of fiber optic delivery devices with accessories . The system uses the same type of laser delivery devices as the predicate.

The PolyScope Flexible Endoscope is indicated in flexible endoscopic procedures for diagnostic and therapeutic applications where flexible endoscopes are standard of care including: - Gastroenterology, including procedure of the Biliary system involving the hepatic and pancreatic ducts. - Urology, including procedures involving the bladder, ureter, renal pelvis and kidney. The PolyScope Xenon-Endoscopic light source LS 200 provides white examination light (sunlight spectrum) for all endoscopic applications including: - During video endoscopy. - During fiber endoscopy. - During micro-endoscopy. - During endoscopy using rigid optics. - During usage of forehead illumination.

The PolyScope Flexible Endoscope is comprised from two main components: a disposable, flexible, steerable mini-endoscope and a flexible, modular, reusable optical disposable, Holters, etc. to the catheter to allow the visualization of the desired area. The PolyScope LS 200 XENON-Endoscopic light source provides white examination light (sunlight spectrum) for all endoscopic applications including: - During video endoscopy. - During fiber endoscopy. - During micro-endoscopy. - During endoscopy using rigid optics. - During usage of forehead illumination.

The intended use of the AcuPulse series is for the vaporization, incision, excision, ablation, or coagulation 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 AcuPulse series 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 AcuPulse laser 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: - Keratoses. including actinic and sebortheic 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 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/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 The AcuPulse laser is indicated for use in podiatry 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) matrixectomy Otolaryngology (ENT) The AcuPulse laser is indicated for laser incision, 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, 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 tonsilar cryptolysis and 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) - 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 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 AcuPulse laser is indicated for use in gynecology 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 - Vaporization, 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 of adhesions - Salpingostomy - Oophorectomy - Fimbrioplasty - Metroplasty - Microsurgery (tubal) - Uterine myomas and fibroids - Ovarian fibromas and follicle cysts - Uterosacral ligament ablation - Hysterectomy Neurosurgery Indications The AcuPulse laser is indicated for laser incision, 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, meningiomas (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 Indications The AcuPulse laser is indicated for incision, excision, 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 AcuPulse laser is indicated for 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 AcuPulse laser is indicated for 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 AcuPulse 30 and 40 series is the next generation of Lumenis CO2 lasers. The new product will retain the same console, articulated arm, delivery devices and other basic features of the current Compact 20C, 30C & 40C series, while integrating improved versions of the GUI and SurgiTouch scanner currently used with the UltraPulse SurgiTouch. The AcuPulse 30 and 40 Carbon Dioxide Laser is an advanced computer-controlled, user friendly CO2 laser system based on a sealed-off CO2 laser tube providing up to 30 or 40 Watts (model dependent) on tissue. The system incorporates the CO2 laser tube within the main cabinet, an articulated arm beam delivery system and attachable laser accessories. The system is activated for laser emission by a footswitch. This system incorporates a DC-excited CO2 laser tube. The CO2 laser wavelength falls in the mid-infrared region of the electromagnetic spectrum. This wavelength is invisible to the human eye. CO2 laser energy is readily absorbed by water in tissue. Since soft tissue is comprised primarily of water, CO2 laser energy can be used effectively for the excision, incision, ablation, vaporization and coagulation of soft tissue

The intended use for the Selecta Family of Ophthalmic Laser Systems (Selecta 1064, Selecta SLT, Selecta Duet, LaserLink S, Selecta Duo, and Selecta Trio) and Accessories are as follows: - Selecta 1064: Photodisruption of ocular tissue using light energy emitted by a Nd:YAG laser, includinq discission of the posterior capsule of the eye (posterior capsulotomy), and discission of pupillary membranes (pupillary membranectomy) in aphakic and pseudophakic patients, and iridotomy/iridectomy. - Selecta SLT: Selective laser trabeculoplasty. - Selecta Duet: Photodisruption of ocular tissue using light energy emitted by a Nd: YAG laser, including discission of the posterior capsule of the eye (posterior capsulotomy), and discission of pupillary membranes (pupillary membranectomy) in aphakic and pseudophakic patients, and iridotomy/iridectomy and selective laser trabeculoplasty. - LaserLink S: Laser delivery system for use by an ophthalmologist in the treatment of ocular tissue. The laser delivery system is intended for a variety of ophthalmic uses, including the indications specified in the laser operator manual. Refer to the laser operator manual, General Intended Use section. - Selecta Duo: Photodisruption of ocular tissue using light energy emitted by a Nd:YAG laser, including discission of the posterior capsule of the eye (posterior capsulotomy), and discission of pupillary membranes (pupillary membranectomy) in aphakic and pseudophakic patients, and iridotomy/iridectorny and retinal photocoaqulation. - Selecta Trio: Photodisruption of ocular tissue using light energy emitted by a Nd:YAG laser, including discission of the posterior capsule of the eye (posterior capsulotomy), and discission of pupillary membranes (pupillary membranectomy) in aphakic and pseudophakic patients, and iridotomy/iridectomy, retinal photocoaqulation and selective laser trabeculoplasty.

The Lumenis Selecta is a fully integrated, high-performance diagnostic slit lamp and therapeutic laser delivery system. Selecta has all of the standard controls and functions of a diagnostic slit lamp and is intended for use in eve examination of the anterior segment, from the cornea epithelium to the posterior capsule. The Lumenis Selecta is also an ophthalmic surqical laser designed for performing photodisruption of ocular tissue using laser energy emitted by a Nd:YAG laser including discission of the posterior capsule of the eye (posterior capsulotomy), discission of pupillary membranes (pupillary membranectomy), and iridotomy/iridectomy; and selective laser trabeculoplasty. The Selecta Family of Ophthalmic Lasers is comprised of: Selecta 1064: A Nd:YAG laser providing Q-switched laser pulses at a wavelength of 1064 nm for use in photodisruption of ocular tissue (posterior capsulotomy, papillary membranectomy, and iridotomy). Selecta SLT: A Nd:YAG laser providing Q-switched laser pulses at a wavelength of 532 nm for use in selective laser trabeculoplasty. Selecta Duet: A Nd:YAG laser providing Q-switched laser pulses at a wavelength of 1064 nm for use in photodisruption or Q-switched frequency doubled laser pulses at a wavelength of 532 nm for use in selective laser trabeculoplasty, depending on the mode selected. LaserLink S: Laser delivery adapter that may be coupled to each of the above Selecta models and connected to a currently cleared Lumenis 532 nm retinal photocoaqulator (Novus Spectra, Novus Varia) to allow use of the slit lamp to deliver 532 nm continuous wave laser energy for retinal photocoagulation. Selecta Duo: A Nd:YAG laser providing Q-switched laser pulses at a wavelength of 1064 nm for use in photodisruption or Q-switched 532 nm continuous wave laser energy for retinal photocoagulation. Selecta Trio: A Nd:YAG laser providing Q-switched laser pulses at a wavelength of 1064 nm for use in photodisruption, Q-switched frequency doubled laser pulses at a wavelength of 532 nm for use in selective laser trabeculoplasty, or Q-switched 532 nm continuous wave laser energy for retinal photocoagulation, depending on the mode selected. The Selecta produces short, individual pulses of focused laser light with wavelengths of either 1064 nm or 532 nm. depending on the selected operational mode. Using a slit lamp microscope and aiming beam, the pulsed light is accurately targeted on a structure within the patient's eye. When the photodisruptor mode is selected, the treatment wavelength is 1064 nm. A twin-aiming beam targets the area of tissue disruption. The energy contained within a single short pulse is concentrated by focusing to a very small spot size so that plasma formation occurs at the focal point. This creates an acoustic wave which disrupts nearby tissue. When the SLT mode is selected, the treatment wavelength is 532 nm. A coaxial aiming beam targets the trabecular meshwork via a contact lens. The SLT treatment laser provides a low energy, short pulse of laser light that produces a thermal effect in pigmented cells in the trabecular meshwork. If the optional LaserLink S adapter is attached to the Selecta system and the compatible Lumenis Spectra 532 nm retinal photocoagulator laser, the Selecta works strictly as a diagnostic slit lamp - all photodisruptor and SLT laser functions are disabled. The Laser delivery adaptor is used for treatments specifically cleared for the compatible laser retinal photocoaqulator.

LightSheer® Pulsed Diode Array Laser Systems are indicated for use in surgical, aesthetic, and cosmetic applications in the medical specialties of general and plastic surgery, and dermatology. The LightSheer® Pulsed Diode Array Laser Systems are intended for use on all skin types (Fitzpatrick skin types I – VI), including tanned skin. LightSheer® Duet™ Laser Systems with LightSheer® ET™ Laser Handpiece is intended for the treatment of vascular lesions, including angiomas, hemangiomas, telangiectasia and other benign vascular lesions, and the treatment for pseudofolliculitis barbae. The LightSheer® Duet™ Laser System with LightSheer® ET™ Laser Handpiece is also intended for hair removal, permanent hair reduction, and the treatment of benign pigmented lesions and leg veins. LightSheer® Duet™ Laser Systems with LightSheer® HS™ Laser Handpiece is intended for the treatment of benign vascular and pigmented lesions, hair removal, and permanent hair reduction.

The LightSheer Duet Laser System is a non-invasive aesthetic laser. The system delivers pulsed infrared laser light with a wavelength ranging from 790 - 950 nm (800 nm nominal) and has two unique treatment handpieces. One handpiece is the LightSheer® ET™ handpiece, which delivers laser energy through a 9 x 9 mm tip up to 90 J maximum. The settings for this handpiece are selectable pulse duration from 5 – 400 ms, selectable fluence from 10 - 100 J/cm2 and a pulse repetition rate up to 3 Hz maximum. The second handpiece is the LightSheer® HS™ handpiece, which delivers laser energy from a 22 x 35 mm diode array up to 45 J maximum. The settings for this handpiece are pulse duration from 10 - 30 ms, selectable fluence from 3 - 5.2 J/cm2 and multiple pulsing up to 3 pulses. The complete system consists of a console and two handpieces connected to the system by umbilical cables. In standard use, the handpiece is pressed against the patient's skin and a pulse of light is delivered. To initiate energy output, the system requires redundant activation of the handpiece enable button and the handpiece trigger button while the system is in the Ready mode. The LightSheer ET handpiece tip is watercooled to provide active skin cooling. The LightSheer HS handpiece tip uses vacuum and lower laser energy densities which reduces skin heating. The physician is able to control the settings of laser energy from the LCD display on the main console.

photodisruption of ocular tissue using light energy emitted by a Nd: Y AG Selecta 1064: laser, including discission of the posterior capsule of the eye (posterior capsulotomy), and discission of pupillary membranes (pupillary membranectomy) in aphakic and pseudophakic patients, and iridotomy/iridectomy selective laser trabeculoplasty Selecta SLT: photodisruption of ocular tissue using light energy emitted by a Nd: Y AG Selecta Duet: laser, including discission of the posterior capsule of the eye (posterior capsulotomy), and discission of pupillary membranes (pupillary membranectomy) in aphakic and pseudophakic patients, and iridotomy/iridectomy; and selective laser trabeculoplasty laser delivery system for use by an ophthalmologist in the treatment of LaserLink S: ocular tissue; laser delivery system indicated for use for a variety of ophthalmic uses, including the indications specified in the laser operator manual. Refer to the laser operator manual, Indications for Use section. The Selecta 1064, Selecta SLT and Selecta Duet Ophthalmic Lasers are also intended for use as a diagnostic slit lamp, specifically, An AC-powered slit lamp biomicroscope intended for use in eye examination of the anterior segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affects the structural properties of the anterior segment. same indications for use as a Selecta 10648 and LaserLink S slit lamp Selecta Duo: delivery device with a currently cleared Lumenis 532nm photocoagulator Selecta Trio: same indications for use as a Selecta Duet and LaserLink S slit lamp delivery device with a currently cleared Lumenis 532nm photocoagulator

The Lumenis Selecta is a fully integrated flash lamp pumped, solid state, Nd:YAG ophthalmic surgical laser system intended for use in the treatment of ocular pathology and for use as a diagnostic slit lamp. The Selecta Family of Ophthalmic Lasers, Delivery Device and Accessories are comprised of the following configurations: Selecta 1064 - a Nd:YAG laser providing Q-switched laser pulses at a wavelength of 1064nm for use in photodisruption of ocular tissue (posterior capsulotomy, papillary membranectomy, iridotomy). The 1064nm treatment beam delivers a 4 nsec, 0.3-10mJ adjustable and selectable single, double or triple pulse of energy. It is conditioned through beam shaping optics to generate a photodisruption micro pulse of plasma at a precision location relative to the visual focal plane (located at slit lamp center of adjustable rotation) and along the slit lamp objective lens axis. A twin aiming beam is also focused by the slit lamp objective to a converging 20um spot located at the focal point of the lens. The focal point of photodisruption is adjustable 0-350μm in the posterior direction by the physician relative to this convergence of the twin aiming beams. Selecta SLT® - a Nd:YAG laser providing Q-switched frequency doubled pulses at a wavelength of 532nm for use in selective laser trabeculoplasty. The treatment beam delivers a 4nsec, 0.1-2mJ adjustable single pulse of energy. The aiming and treatment beams are coaxial with each other and focused by the slit lamp objective to a 400um spot at the focal point of the lens. Selecta Duet® - a Nd:YAG laser providing Q-switched laser pulses at a wavelength of 1064 nanometers for use in photodisruption or Q-switched frequency doubled pulses at a wavelength of 532nm for use in selective laser trabeculoplasty, depending upon the mode selected. The Selecta Duo contains two aiming beam modules that produce a single beam for the 532nm mode and a dual beam for the 1064nm mode, respectively. LaserLink S - a laser slit lamp delivery adaptor that may be coupled to each of the above Selecta models and connected to a currently cleared Lumenis 532nm photocoagulator to allow the physician to use the Selecta slit lamp to deliver 532nm continuous wave laser energy for photocoagulation. Selecta Duo - a Selecta 1064® and LaserLink S slit lamp delivery device with a currently cleared Lumenis 532nm photocoagulator Selecta Trio - a Selecta Duet and LaserLink S slit lamp delivery device with a currently cleared Lumenis 532nm photocoagulator Selecta SLT and LaserLink S with a currently cleared Lumenis 532nm photocoagulator

The Novus 3000 Laser System is intended for use in the treatment of ocular pathology. The Novus 3000 Laser System is indicated for use in photocoagulation of both anterior and posterior segments including: - Retinal photocoagulation, panretinal photocoagulation and intravitreal endophotocoagulation of vascular and structural abnormalities of the retina and choroid including: - proliferative and nonproliferative diabetic retinopathy; - choroidal neovascularization; - branch retinal vein occlusion; - age-related macular degeneration; - retinal tears, detachments; - retinopathy of prematurity. - Iridotomy, iridectomy and trabeculoplasty in angle closure glaucoma and open angle glaucoma. Laser Indirect Ophthalmoscope The Laser Indirect Ophthalmoscope is indicated for the delivery of laser energy in eyes with retinal pathology. The Laser Indirect Ophthalmoscope is indicated for use in the following ophthalmic treatments and conditions: diabetic retinopathy (panretinal photocoagulation); peripheral neovascularization, retinal breaks, detachments, and tears, lattice degeneration, pneumatic retinopexy reattachment procedures, segmental peripheral photocoagulation; segmental photocoagulation; cloudy vitreous cavities; pediatric retinal repairs (under general anesthesia), delivery of laser energy through small pupils or to eyes with focal lens opacities. Endophotocoagulation When used with a Novus 3000 Laser System, the Acculite EndoOcular Probes (Acculite EndoOcular Probe, Acculite Aspirating EndoOcular Probe, and Acculite Illuminating EndoOcular Probe) are intended for use in the following ophthalmic applications: photocoagulation of the anterior and posterior segment, including: anterior segment treatment in the surgical management of glaucoma; endophotocoagulation in vitreoretinal surgery, including panretinal photocoagulation, retinopexy, and treatment of neovascularization. The laser delivery function of the Acculite Acculite EndoOcular Probes (Acculite EndoOcular Probe, Acculite Aspirating EndoOcular Probe and Acculite Illuminating EndoOcular Probe) is indicated for use in ocular surgery to deliver laser energy to the treatment area selected by the surgeon. The aspiration function of the Acculite Aspirating EndoOcular Probe is indicated for use when unwanted fluid is present in the eye during ocular surgery, causing refraction or scattering of the laser beam from the intended treatment site. The illumination function of the Acculite Illuminating EndoOcular Probe is indicated for use during ocular surgery to illuminate the interior of the eye.

Lumenis, Inc.'s Novus® 3000 Laser System with the Delivery Devices is an air cooled, diode-pumped, solid state, Nd: YAG Laser System, which produces a wavelength of 532 um of laser light with a treatment beam output ranging from 50 mw to 3.0 W. The main parts of the Novus® 3000 system include the laser console, a footswitch, a remote control and assorted laser accessories.

The Aluma Skin Renewal System is intended for use in Dermatologic and The Anama UKIN Keneral Systems of the non-invasive treatment of wrinkles and rhytids.

The Aluma Skin Renewal System is a non-invasive, non-ablative unit consisting of a user interface, a programmable logic controller (PLC), an RF power module, internal electronics, a vacuum pump, and a treatment handpiece with interchangeable tips (small and large). The interface allows the selection of treatment parameters by pressing on the treatment buttons; an LCD screen displays the current treatment settings. The PLC is a specially configured computer that provides the operational and safety function of the system. The RF power module provides RF energy to the handpiece, producing a sinusoidal signal at a 468 kHz frequency