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The Modified Alma Lasers Soprano XL™ Family of Multi-Application and Multi-Technology Platforms [Soprano de, Soprano de and Soprano (5) is intended for use in dermatologic and general surgical procedures. The Modified Alma Lasers Soprano XL™ Family of Multi-Application and Multi-Technology Platforms [Soprano ^', Soprano * and Soprano "CE] includes Diode Laser and NIR Modules Diode Laser Modules: The indications for use for the 810mm Modified Diode Laser Module 1.2 cm² include: - The Hair Removal (HR) and Super Hair Removal(SHR) Mode is intended for permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regimen. - The treatment of benign vascular and pigmented lesions.(The Laser Blanch (LB) Mode) . Use on all skin types (Fitzpatrick I-VI), including tanned skin.(HR. SHR and LB Modes) Optional Tapered Light Guide: It is intended for the same use as the device. The indications for use for the 810nm Modified Diode Laser Module 2 cm² include: - . The Hair Removal (HR) and Super Hair Removal(SHR) Mode is intended for permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regimen. - Use on all skin types (Fitzpatrick I-VI), including tanned skin.(HR, and SHR Modes) The indications for use for the 755nm Diode Laser Module include: - The Hair Removal (HR) and Super Hair Removal(SHR) Mode is intended for permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regimen. - The treatment of benign vascular and pigmented lesions.(The Laser Blanch Mode) 트 - Use on all skin types (Fitzpatrick I-VI), including tanned skin.(HR, SHR and Laser Blanch Modes) . NIR Modules The Alma Lasers NIR Modules intended use is to emit energy in the near infrared (NIR) spectrum to provide topical heating. The indications for use for NIR Modules are : - Elevating the tissue temperature for the temporary relief of minor muscle pain and joint pain and stiffness, 트 - The temporary relief of minor joint pain associated with arthritis, - 프 The temporary increase in local circulation where applied, and - 미 The relaxation of muscles; may also help muscle spasms, minor sprains and minor muscular back pain.

The Modified Alma Lasers Soprano XL™ Family of Multi-Application and Multi-Technology Platforms [Soprano XL, Soprano ™ and Soprano "CE] is a modification to previously cleared Soprano Family XL ™M Multi Application Platform [Soprano **] The relevant K number is K102716 Soprano 40, the new addition to the family has hand pieces with multiple wavelengths, spot sizes and supports both Diode Laser and Near Infrared (NIR) Technologies. The Soprano 40 comprises of the following major components: 1. The main console unit 2. Footswitch. 3.

Intended Use The Alma Diode Tabletop Laser is intended for use in dermatologic and general surgical procedures. Indications for Use The Alma Diode Tabletop Laser includes three possible diode laser modules depending on the customer order. Diode Laser Modules: The indications for use for the 810nm Alma Diode Tabletop Laser include: - The Alma 810nm diode tabletop laser is indicated for endovenous laser surgery for saphenous incompetent veins. The indications for use for the 980 nm Alma Diode Tabletop Laser include: -The Alma 980nm diode tabletop laser is indicated for use in endovenous occlusion of the greater saphenous vein in patients with superficial vein reflux. The Alma 980nm diode tabletop laser is further indicated for laser assisted lipolysis. The indications for use for the 1470nm Alma Diode Tabletop Laser include: -The Alma 1470nm diode tabletop laser is indicated for use in endovenous occlusion of the greater saphenous vein in patients with superficial vein reflux. The Alma 1470nm diode tabletop laser is further indicated for laser assisted lipolysis.

The Alma Diode Tabletop Laser is comprised of the following major components: - 1. The main console unit - 2. Footswitch. - 3. Accessories

The Alma Lasers ALEX755 Module to be used with the Harmony XL™ Multi-Application Platform is indicated for permanent hair reduction. Also indicated for the treatment of vascular lesions and benign pigmented lesions.

The Alma Lasers ALEX755 Module is an additional module to the existing Alma Lasers. Ltd. Harmony XLTM Multi-Application Platform (previously cleared under K072564). The pistol-shaped Alex755 laser module incorporates a solid state Alexandrite rod laser medium and a xenon flash lamp as the heart of the optical bench. The flash lamp pumped Alexandrite rod emits light through an aperture located on the module tip. The laser beam is delivered when the operator presses both the footswitch, and the handpiece trieger. The Alma Lasers ALEX755 Module is comprised of the following components; An 'umbilical' cable and connector, that is permanently attached to the ALEX755 module body and semi-permanently attached to the laser system. Electrical cables (to provide power to the light source and to connect to a memory device that identifies the module). A supply and return water line (to remove the heat generated). Module body (shells) housing the module internals and connecting to the umbilical. The operator holds the handpiece by its handle in order to position the module tip against the patient's skin. Optional air-cooling can be provided.

The SOPRANO XL™ Multi-Application Platform includes a Diode Laser Module and an optional NIR Module. The Diode Laser Module: The HR Mode is intended for hair removal, permanent hair reduction. The LaserBlanche Mode is intended for the treatment of benign vascular and pigmented lesions. The NIR Module is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating the tissue temperature for the temporary relief of minor muscle pain and joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and the relaxation of muscles; may also help muscle spasms, minor sprains and strains, and minor muscular back pain. The SOPRANO XL™ Multi-Application Platform is intended for use on all skin types (Fitzpatrick skin types I-VI), including tanned skin.

The Soprano XL Multi-Application Platform features an additional indication for the treatment of benign vascular and pigmented lesions introduced to its Diode Module compared to the existing Alma Lasers, Ltd. (former MSq., Ltd.) Soprano Diode Laser System, previously cleared under K052874 for hair removal and long-term hair reduction. The Soprano XL system is indicated for use on all skin types (Fitzpatrick Skin Types I-VI), including tanned skin. The Soprano XL Multi-Application Platform is a multi-application, multi-technology platform that supports the following technologies: · Diode laser technology · Near-infrared light technology (NIR) Both the Soprano and Soprano XL systems consist of a console, a diode module and a footswitch. The module is pressed against the patient skin and a laser pulse is delivered when the module trigger and the footswitch are activated. The module tip is cooled by the cooling system. Output parameters and other system features are controlled from the touch-screen control panel on the console, which provides an interface to the system micro-controller through an LCD touch-screen.

Intended Use: The Accent UniForm Massager handpiece/module is intended to be used with the Alma Lasers Family of Accent™ RF Systems for use in dermatologic and general surgical procedures. Indications for Use: The massage component of the Alma Lasers Accent UniForm Massager Handpiece/Module is intended for use with the Alma Lasers Family of Accent RF Systems to provide: Temporary reduction in the appearance of cellulite. Simultaneous application of RF energy and mechanical manipulation of the skin by the Alma Lasers Accent UniForm Massager Handpiece/Module is intended for use with the Alma Lasers Family of Accent RF Systems to provide: Temporary reduction in the appearance of cellulite.

The Accent UniForm Massager handpiece/module is a cleanable, reusable radiofrequency (RF) energy delivery and skin mechanical manipulation/massage device (accessory) intended for use with the Alma Lasers Family of Accent RF Systems. The Accent UniForm Massager handpiece/module is comprised of the following main components: Handpiece Tip with Massage Ring, Handpiece Body (Handle used for holding the handpiece, A RF emission indicator - blue LED illuminates prior to- and during the RF energy emission, A Thermo-electric cooler - integrated within the handpiece, provides contact cooling, A Umbilical cable - contains hot and cold water tubes (cooling system), RF-power cable and the communication cable that controls the operation of the handpiece, A Handpiece connector - connects the handpiece to its port. It incorporates an integrated impedance matching network (IMN) and a memory chip (i-button) that stores information about the handpiece and the parameter settings. It also houses the water tube quick-connectors.)

The Alma Lasers ThermoXEL™ CO2 Laser System and Delivery Device Accessories are intended for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: aesthetic surgery (dermatology and plastic surgery), podiatry, gynecology, neurosurgery, orthopedics (soft tissue), arthroscopy (knec). The Alma Lasers ThermoXEL™ CO2 Laser System is cleared for use for the particular indications 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 the treatment of: - wrinkles, rhytids, and furrows (including fines lines and texture irregularities) Clinical literature demonstrates that skin resurfacing of wrinkles, rhytids, and furrows with CO2 laser increases the amount of sub-epidermal collagen. Dermatology & Plastic Surgery, continued 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, sebortheic wart, and verruca seborrheica; - vermillionectomy of the lip; - cutaneous horns; - solar/actinic elastosis; - chelitis, including actinic chelitis; - 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; Dermatology & Plastic Surgery, continued - nevi, including spider, epidermal and protruding; - neurofibromas; - laser de-epithelialization; - tricoepitheliomas; - xanthelasma palpebrarum; - syringoma Laser ablation, vaporization and /or excision for complete or partial nail matrixectorny. Vaporization/coagulation of: - benign/malignant vascular/avascular skin lesions; - Moh's Surgery; - Lipectomy; - Verrucae and seborrhoecae vulgares, including paronychial, periungal, and subungaual warts. Laser incision and /or excision of soft tissue for the performance of upper and lower eyelid blepharoplasty. Laser incision and /or excision o 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 or partial matrixectomy. Otolaryngology (ENT) Laser incision, excision, ablation and/or vaporization of soft tissue in otolaryngology the 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; Otolaryngology (ENT), continued - laser/tumor surgery in the larynx, pharynx, nasal, ear and oral structures and tissue; - Zenker's Diverticulum/pharyngoesophageal diverticulum Jendoscopic laser-assisted esophagodivertuculostomy (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, trachcobronchial/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 UPP): - 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/gingivoctomy. Gynecology (GYN) Laser incision, excision, ablation and/or vaporization and of soft tissue in gynecology (GYN) for the treatment of; - conization of the cervix, including cervical intraepithelial neoplasia (CIN), vulvar and vaginal intraepithelial neoplasia (VIN, VAIN); - condyloma acuminate, including cervical, genital, vulvar, perincal, 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; GYN Laparoscopy, continued - ovarian fibromas and follicle cysts; - uterosacral ligament ablation; - hysterectomy. Neurosurgery Laser incision, excision, ablation and/or vaporization and 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 and of soft tissue in orthopedic surgery. Applications include: Arthroscopy - menisectomy; - chodromalacia; - chondroplasty; - ligament release (lateral and other); - excision of plica; - partial synovectomy. General - deridement of traumatic wounds; - debridement of decubitus and diabetic ulcers; - microsurgery; - artificial joint revision; - PMMA removal. General/Thoracic Surgery Incision, excision and vaporization and 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; General/Thoracic Surgery, continued - 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; Dental/Oral Surgery, continued - 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 and of soft tissue in genitourinary procedures. Applications include: - benign and malignant lesions of external genitalia; - condyloma; - phimosis - erythroplasia. The Alma Lasers ThermoXEL™ CO2 Laser System Pixel Handpieces are indicated for use in soft tissue for: Dermatology & Plastic Surgery - Skin resurfacing

The Alma Lasers ThermoXEL™ CO2 Laser System and delivery device accessories consist of the following major components: - 1. Laser system console (containing the optical bench assembly and laser, the microcontroller control electronics and system software, the high voltage power supply, the laser cooling system, the compressed air-purge system, and the service panel) - a. LCD control panel - b. Keypad - 2. 7-joint articulated arm - 3. Footswitch - 4. Variety of Delivery Device Handpieces (single spot, scanner, pixel)

The Alma Lasers Family of Thermo-XEL Handpieces is intended for use in surgical applications requiring the ablation, vaporization, and coagulation of soft tissue for compatible CO2 and 2940 nm Er:YAG laser systems cleared for use in the medical specialty of Dermatology and Plastic Surgery to which they are attached. The Alma Lasers Family of Thermo-XEL Handpieces is indicated for use in soft tissue for: DERMATOLOGY AND PLASTIC SURGERY: Skin resurfacing

The Alma Lasers Family of Thermo-XEL Handpieces is comprised of the following main components: Thermo-XEL Handpiece body. Adapter attachments: CO2 laser adapter attachment, as required, to attach the handpiece body to the qualified CO2 or Er: Y AG laser system Er:YAG laser adapter attachment, as required, to attach the handpiece body to the qualified Er: Y AG laser system The Alma Lasers Family of Thermo-XEL Handpieces are provided as a non-sterile, cleanable, multiple use laser energy delivery device (accessory). The proximal end of the handpiece is designed to be attached, using the laser adapter, to the distal end of the articulated arm of compatible CO2 (10.6 um) or Er.YAG (2940 nm) laser systems as qualified by Alma Lasers for use with the Thermo-XEL Handpiece.

The Alma Lasers Harmony XL™ Multi-Application Platform is intended for use in dermatologic and general surgical procedures. The Harmony XL™ Multi-Application Platform is intended for use in aesthetic, cosmetic, and surgical applications requiring the ablation, vaporization, excision, and photothermolysis (photocoagulation or coagulation) of soft tissue in the medical specialties of dermatology, general and plastic surgery, endoscopic/laparoscopic general surgery, gastroenterology, gynecology, otorhinolaryngology (ENT), neurosurgery, oculoplastics, oral surgery, ophthalmology (skin around the eyes), orthopedics, pulmonary/thoracic surgery, and urology for surgical and aesthetic applications.

The Alma Lasers Harmony XL™ Multi-Application Platform is comprised of the following main components: The main console unit that incorporates the touch-screen control panel, power supply modules, cooling system, switching module, service panel and isolating transformer. Variety of handpieces and attachment accessories. Footswitch.

The Alma Lasers NIR Module is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating the tissue temperature for the temporary relief of minor muscle pain and joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and the relaxation of muscles; may also help muscle spasms, minor sprains and strains, and minor muscular back pain.

The Alma Lasers NIR Module is an additional module to the existing Alma Lasers, I.td. (former MSq.) Soprano Diode Laser System cleared under K052874. The Alma Lasers NIR Module is comprised of the following components: - An 'umbilical' cable and connector, that is permanently attached to the NIR module body and semi-permanently attached to the laser system that houses: - Electrical cables (to support the thermoelectric coolers (TFC) associated with the chilled sapphire window, to provide power to the pulsed light source (quartz tube), and to connect to a memory device that identifies the module) - A supply and return water line (to remove the heat generated by the infrared lamp and thermoelectric cooler) - Module body (shells) housing the module internals and connecting to the umbilical. The light source emits a pulse when it is activated by pressing the footswitch. The light passes through an aperture with a filter, into a lightguide that is located on the module tip. The operator holds the handpiece by its handle in order to position the lightguide against the patient's skin. The module tip is TEC-cooled to provide contact skin cooling. The module contact cooling mechanism can be turned on or off by touching the appropriate soft-key in the bottom-left corner of the LCD control panel. The temperature at the skin surface does not exceed 40°C. The NIR module is operated only by pressing the footswitch. The proximal end of the umbilical is semi-permanently attached to the laser system console and the distal end is permanently attached to the body of the NIR delivery module. The Alma Lasers NIR Module is removable by either the user or an authorized filed service engineer for replacement at the proximal end.

The Alma Lasers Family of Accent™ RF Systems [Accent, Accent XL] is intended for use in dermatologic and general surgical procedures. The Alma Lasers Family of Accent™ RF Systems [Accent, Accent XL] is indicated for the non-The Alma Baser Painty of wrinkles and rhytids using a combined treatment with Unipolar and Bipolar handpieces.

The Alma Lasers Family of Accent™ RF Systems [Accent, Accent XL] is comprised of the following main components: - Console . - A Bipolar RF handpieces (normal and small-tip) - A Unipolar RF handpieces (normal and unilarge) - Control panel . - Footswitch. .