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The Lumenis Stellar M22 system has connection capability with the following available treatment modules, for multi-application treatment options. All modules are designed for aesthetic and dermatological skin procedure application, as follows: - IPL with a spectrum of 400-1200nm (with different filters) is indicated for: - Benign epidermal lesions, including dyschromia, hyperpigmentation, melasma and ephelides (freckles). - 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 and spider 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). - Multi-Spot Nd:YAG Laser, with a wavelength of 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 (venulectasias) and reticular veins (0.1 - 4.0 mm diameter) of the leg. - The non-ablative treatment of facial wrinkles. - 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 1565nm ResurFX module, with a wavelength of 1565 nm, is indicated for: - Use in dermatological procedures requiring skin resurfacing and coagulation of soft tissue. - Q-Switched Nd:YAG Laser, with a wavelength of 1064 nm, is indicated for: - Treatment of pigmented lesions. - Removal of dark tattoos. (*) Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regimen.

The Lumenis Stellar M22 System is multi-application, multi-technology system intended for use in aesthetic dermatologic procedures. The Stellar M22 System operates with four (4) treatment handpieces options (for connection capability), within serial operational mode: - Intense Pulsed Light (IPL) handpiece; - Multi-Spot Nd:YAG Laser handpiece; - ResurFX Laser module and 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 Stellar M22 for Intense Pulsed Light (IPL) and Laser Systems: - The Stellar IPL handpiece has nine (9) 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 530650& 900-1200 nm. Further, the IPL handpiece has three (3) Sapphire Cool LightGuides available with sizes of: 15mm x 35mm, 8mm x 15 mm, 6 mm diameter. - The Multi-Spot Nd:YAG handpiece has three (3) different LightGuides available in sizes of: 2mm x 4mm, 6 mm, and 9 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, while the metal treatment tips are available in seven (7) different sizes of: 2, 2.5, 3.5, 4, 5, 6 and 8 mm.

The FoLix System, with wavelength of 1565 mm. is indicated for improving the appearance of scalp hair in adult males and females with Fitzpatrick skin type I to IV who are seeking treatment for hair loss.

The FoLix™ is a laser system intended to be used for improving the appearance of scalp hair in adult males and females with Fitzpatrick skin type I to IV seeking treatment for hair loss, as well as, for the identical set of functions as the predicate device. The FoLix™ laser system with a wavelength of 1565 nm and consists of the following: - The laser console includes a power supply unit, a Laser module (+ aiming beam), a control ● unit and a PC module. The laser beam is transferred to the handpiece via fiber optics. - The handpiece includes a scanner module built of two mirrors that are controlled by two ● motors directing the Laser beam to desired target tissue. - The handpiece uses a tip to align the Laser beam focus with the target tissue, enabling a . treatment shape size and a thermo-electric cooler (TEC). The FoLix™ is intended for professional use only.

The Modified ULTRApulse Alpha CO2 Laser System, Delivery Devices and Accessories (members of the UltraPulse CO2 Laser Systems Family) is indicated for use in surgical or aesthetic applications requiring: ablation, vaporization, excision, or coagulation of soft tissue in medical specialties including; dermatology and plastic surgery (aesthetic), podiatry, gyneoology, general and thoracic surgery, 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). - -Laser skin resurfacing (ablation and/or vaporization) of soft tissue for the reduction, removal, and/or treatment of: - · Keratoses, including actinic and sebortheic keratosis, sebortheic wart and verruca sebortheica. - · 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 and 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 - 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 matrixectomy Gynecology (GYN) Laser incision, excision, ablation and/or vaporization of soft tissue in gynecology for the treatment of: - · vulvar and vaginal intraepithelial neoplasia (VIN, VAIN) - · Condyloma acuminata, including genital, vulvar, perineal, and Bowen's disease (Erythrolasia 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 - Benign and malignant tumors - · Hemangiomas General Surgery - Debridement of traumatic wounds - Debridement of decubitus and diabetic ulcers - · Microsurgery - · Artificial joint revision - PMMA removal 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 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 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 Lumenis Be modified ULTRApulse Alpha CO2 Laser System, Delivery Devices and Accessories when used in conjunction with FemTouch and FemX, is indicated for the vaporization, ablation and coagulation of body soft tissue in medical specialties including aesthetic (dermatology and plastic surgery), podiatry, gynecology, general and thoracic surgery. The use with the scanning unit is indicated for ablative skin resurfacing.

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The subject F65 has connection capability with the following available treatment handpieces, for multi-application 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 400-1200 nm (with 9 different filters) is indicated for: - o Benign epidermal lesions, including dyschromia, hyperpigmentation, melasma, and ephelides (freckles) - o Cutaneous lesions, including warts, scars and striae - o Benign cutaneous vascular lesions, including port wine stains, hemoangiomas, facial, truncal and leg telangiectasias, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations - o Removal of unwanted hair and to effect stable long term, or permanent* hair reduction in skin types I-V through selective targeting of melanin in hair follicles - o 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: - o The coagulation and hemostasis of vascular lesions and soft tissue, including the treatment and clearance of superficial and deep telangiectasias (venulectasias) and reticular veins (0.1-4.0 mm. diameter) of the leg - o The removal of unwanted hair and to effect table long term, or permanent* hair reduction in skin types I-V through selective targeting of melanin in hair follicles - o The non-ablative treatment of facial wrinkles The F65 module and handpiece, with wavelength of 1565 nm, are indicated for: - o Use in dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue - o Improving the appearance of scalp hair in adult males with Fitzpatrick skin type I to IV who are seeking treatment for hair loss. The Q-Switched Nd:YAG Laser Handpiece with a wavelength of 1064 nm is indicated for: o Removal of dark tattoos o 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 completion of treatment regime.

The Lumenis Be F65 Laser System is intended to be used for the new indication for Improving the appearance of scalp hair in adult males with Fitzpatrick skin type I to IV seeking treatment for hair loss, as well as, for the identical set of functions as the predicate device. The description here is limited to the system module required to support the new indication which is the subject of this 510(k): - The laser console includes a power supply unit, a Laser module (+ aiming beam), a control unit and a PC module. The laser beam is transferred to the handpiece via fiber optics. - . The handpiece includes a scanner module – built of two mirrors that are controlled by two motors directing the Laser beam to desired target tissue. - . The handpiece uses a tip (user may choose from two types) to align the Laser beam focus with the target tissue, enabling a treatment shape size and a tip thermo-electric cooler (TEC). The F65 is intended for professional use only.

· Selecta Duet LED or Digital Duet: Photodisruption of ocular tissue using light energy emitted by a Nd: Y AG laser, including discission of the posterior capsule of the eye (posterior capsulotomy) iridectorny, and selective laser trabeculoplasty. · Selecta LED Trio or Digital Trio: Photodisruption of ocular tissue using light energy emitted by a Nd: Y AG laser, including discission of the posterior capsule of the eye (posterior capsulotomy) iridectorny, selective laser trabeculoplasty, and retinal photocoagulation.

The Selecta Duet LED and Digital Duet subject devices are each a fully integrated, highperformance diagnostic slit lamp and therapeutic laser delivery system. The diagnostic slit lamp is for examining the anterior segment of the eye, from the corneal epithelium to the posterior capsule. The integrated Nd:YAG Q-Switch laser module provides short pulses at the wavelength corresponding with the selected operating mode. Two modes are available: PD (YAG) mode: 1064 nm for photodisruption (PD) of ocular tissues in procedures such as posterior capsulotomy, iridotomy, and iridectomy, and SLT mode: 532 nm for Selective Laser Trabeculoplasty (SLT). The Selecta LED Trio and Digital Trio subject devices are each created by connecting the Selecta LED Duet and Digital Duet, respectively, to a compatible, FDA-cleared, Lumenis continuous 532 nm wavelength photocoagulator laser, via the LaserLink S. When the user connects the Duet to the LaserLink S, the Duet-part acts only as a Slit Lamp since the integrated Duet-laser is disabled and the laser in the external photocoagulator takes over. This combination adds the ability to perform retinal photocoagulation, as well as other indications cleared for the continuous 532 nm wavelength photocoagulator laser. The user disconnects the Duet from the LaserLink S for the system to perform as a Duet.

The YandR System, handpiece and accessories are intended for dermatological procedures requiring the coagulation of soft tissue as follows: 1410 nm Indications for Use: - Fractional skin resurfacing procedures 1927 nm Indications for Use - Fractional skin resurfacing procedures LPTT (Polytherapy) application of 1410 nm and 1927 nm simultaneously - Fractional skin resurfacing procedures

The Lumenis YandR Laser System consists of: - System console (contains the laser diodes, the system software, power supply, and various other electronic and mechanical parts) - Operator control panel with touch-screen technology (GUI) - NAFR handpiece and single-use removable tips - Footswitch and other laser safety accessories The non-ablative fractional NAFR handpiece emits two wavelengths - 1410nm and 1927nm. The 1410nm and 1927nm laser diode modules are located in the console and are coupled into the single handpiece via fiber optics. Through the GUI screen on the system console, the user can select either fractional wavelength, or a combination of both.

The UltraPulse Alpha CO2 Laser System, Delivery Devices and Accessories (members of the UltraPulse CO2 Laser Systems Family) are indicated for use in surgical or aesthetic applications requiring: ablation, vaporization, excision, or coagulation of soft tissue in medical specialties including: dermatology and plastic surgery (aesthetic), podiatry , gynecology, general and oral surgery, dental and oral surgery and genitourinary surgery as follows: The UltraPulse SurgiTouch and UltraPulse Encore CO2 Laser System, Delivery Devices and Accessories (members of the UltraPulse CO2 Laser Systems Family) are indicated for use in surgical or aesthetic applications requiring: ablation, vaporization, excision, or coagulation of soft tissue in medical specialties including: aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (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:

The Lumenis Be Family of UltraPulse CO2 Surgical and Aesthetic Laser Systems, Delivery Devices and Accessories (subject devices) consist of the following devices: Laser Systems - o UltraPulse Alpha (also written as UltraPulse α) - UltraPulse Encore o - UltraPulse SurgiTouch o Delivery Devices and Accessories - o DeepFX Microscanner and disposable tips - UltraScan CPG Microscanner o - o TrueSpot 2.0 mm Collimated Handpiece - o 0.2 mm and 1.0 mm Focused Incisional Handpieces (also called Standard Handpieces) Each UltraPulse laser system is an advanced computer-controlled device with RF - modulated CO2 laser tube technology that emits laser beams at a wavelength of 10,600 or 11,100 nm. Each has an additional diode laser in the red visible spectrum emitting along the same optical path as the CO2 to serve as an aiming beam. Attached to each laser system are the delivery devices and accessories that direct the laser beams to the intended treatment site in the format as selected by the user.

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.

Universal IPL with a spectrum of 400-1200nm (with different filters) is indicated for: Improvement of signs of Dry Eye Disease (DED) due to Meibomian Gland Dysfunction (MGD), also known as evaporative dry eve or lipid deficiency dry eve, in patients 22 years of age and older with moderate to severe signs and symptoms of DED due to MGD and with Fitzpatrick skin types I-IV. IPL is to be applied only to skin on the malar region of the face, from tragus to tragus including the nose (eyes should be fully covered by protective eyewear). IPL is intended to be applied as an adjunct to other modalities, such as meibomian gland expression, artificial tear lubricants and warm compresses.

The Lumenis Stellar M22 System incorporates a touch-screen control panel, power supply modules, cooling unit, switching module and service panel, monitored and controlled by its control software. Selected parameter treatment options and corresponding relevant user information are displayed on the monitor screen. The subject device (ophthalmic use) uses the spectrum range of 400-1200 nm. The cut-off filters used in the Lumenis presets for Universal IPL pigmented lesions treatment with the Stellar M22 system are the 515, 560, 590, 615, 640 or 695nm filters. Each filter cuts off all light with a wavelength shorter than the number indicated on the filter. The filter is inserted inside the handpiece and is exchangeable. Universal IPL skin treatments with the Stellar M22 may use one of the three lightguides, 8x15, 15x35 mm rectangles and 6 mm round, which are supplied as accessories. Lightguides are made of sapphire and couple the optical energy from the module to the treatment site.

The UltraPulse system (UltraPulse DUO models, members of the modified Lumenis Family of UltraPulse SurgiTouch CO2 Surgical Lasers) is indicated for use in surgical applications requiring the ablation, vaporization, excision, 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 UltraPulse system (UltraPulse DUO models, members of the modified Lumenis Family of UltraPulse SurgiTouch CO2 Surgical Lasers) is indicated for use in the performance of specific surgical applications in aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (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). -Laser skin resurfacing (ablation and/or vaporization) of soft tissue for the reduction, removal, and/or treatment of: - Keratoses, including actinic and sebortheic keratosis, sebortheic wart and verruca sebortheica. - · 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 and 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 - 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 matrixectomy Otolaryngology (ENT) -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, 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 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 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 of 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 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 Bowen's disease (Erythrolasia 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 gynecological laparoscopy, for the treatment of: - · Endometrial lesions, including ablation of endometriosis - Excision/lysis adhesions - · Salpingostomy - Oophorectomy/ovariectomy - · Fimbrioplasty - 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, 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 -Incision/excision and vaporization of soft tissue in orthopedic surgery, including the following applications: - Arthroscopy - · Menisectomy - 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 -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 -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 UltraPulse System, member of the UltraPulse SurgiTouch Family of CO2 Surgical and Aesthetic Laser Systems, Delivery Devices and Accessories (K951812 K912029, K96339 K030147 and K151331), is a carbon dioxide laser system based on a Radio Frequency (RF) modulated CO2 laser tube. The modified UltraPulse is based on the following hardware components in the Lumenis Family of UltraPulse CO2 Laser System, Delivery Devices and Accessories: - . 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 laser energy to be transmitted via the delivery device to the target location. - A variety of Free Beam Delivery Device and accessories The modified UltraPulse, similarly to the recent members of the cleared Lumenis Family of UltraPulse CO2 Surgical and Aesthetic Laser Systems. Delivery Devices and Accessories (UltraPulse and UltraPulse DUO models) has a similar proprietary software, which is embedded in the Main Controller, Peripheral Controller units and PC. The modified UltraPulse CO2 Laser System, is a version of the cleared Lumenis Family of UltraPulse CO2 Laser System, Devices and Accessories (see K030147 and K151331 for the latest clearances) with modifications to meet the marketing requirements for a new system with a subset of the supported aesthetic and surgical scanners and accessories. The modified UltraPulse System now supports the Aesthetic Scanners, UltraScan CPG and DeepFX Microscanner used with the cleared UltraPulse SurgiTouch/Encore Systems but with a modern GUI, PC and Operating System. In addition, other hardware, electronic and Software changes were introduced to replace obsolete components. The proposed system relies on the same fundamental underlying technology of the cleared systems with some modifications as compared to the cleared family members. In addition, this submission describes several minor post-clearance modifications to the cleared Lumenis Family of Surgical and Aesthetic Laser Systems, Delivery Devices and Accessories that were the subject of contemporary regulatory analyses that determined that changes could not significantly affect safety or effectiveness. Accordingly, these post-clearance modifications were implemented via internal documentation and no pre-marketing submission was filed. The postclearance modifications, include addition of the modified SurgiTouch Scanner (cleared under K951812 and K022060), called the DeepFX Microscanner to the UltraPulse SurgiTouch/Encore system, almost identical to the AcuScan120 Microscanner cleared with the Lumenis AcuPulse CO2 Laser system (K100415). Modernization of electronics and hardware of all systems to replace outdated parts and to meet new contemporary standards (e.g., IEC 60601-1-2 Ed.4, IEC 60601-1 Ed 3.1), improvements in laser calibration and stability and finally minor software modifications to enhance the user workflow and accessories supported (e.g., addition of treatment Preference and Utilities Screens and Training Videos).