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1064nm mode is indicated for the removal or lightening of unwanted facial or body hair, for skin resurfacing (ablation of epidermal skin layers) in dermatology and aesthetic surgery, benign pigmented lesions (dermal melanocytosis) and tattoo removal for dark and blue inks. The 1064nm fractional mode is indicated for the treatment of wrinkles in Fitzpatrick Skin Types I-IV. 532 nm mode is indicated for tattoo removal including red, blue and light blue and green inks, for the treatment of benign vascular lesions including telangiectasias, spider angiomas, cherry angiomas, spider nevi and the treatment of benign pigmented lesions including Cafe-au-lait birthmarks, solar lentigines, Becker's nevi, freckles nevus spilus and nevus of ota. 532nm mode is also indicated for incision, excision, ablation and vaporization of soft tissue in general dermatology. The Iris Diode is intended for use for vascular lesions, spider veins, spider naevi, teleangiectasis, red superficial veins of the legs and face, pigmented lesions (e.g. cafe-au-lait stains, lentigo), hemangiomas, port wine stains, rosacea.

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The Alma Harmony is intended for use in surgical applications requiring the ablation, vaporization, and coagulation of soft tissue in medical specialties including: aesthetic surgery (dermatology and plastic surgery). Clear Skin Pro 1540nm Applicator: The ClearSkin Pro 1540nm is indicated for : Use in dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue. SupErb 2940nm Applicator: The 2940 nm Er.Y AG Laser Module handard and scanner accessory tips (with and without contactcooling) is indicated for use in soft tissue (skin, cutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs, and glands. Dermatology and Plastic Surgery: Skin resurfacing, Treatment of wrinkles, Epidermal nevi, Telangiectasia, Spider veins, Actinic chelitis, Keloids, Verrucae, Skin tags, keratoses, Scar revision (including acne scars), Debulking benign tumors, Debulking cysts, Superficial skin lesions, Diagnostic biopsies, Decubitus ulcers. General Surgery: Surgical incision, vaporization, ablation, and coagulation of soft tissue where skin incision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors and lesions, tissue ablation, and/or vessel coagulation may be indicated. Genitourinary: Treatment of: Lesions of the external genitalia, urethra and anus, penis, scrotum, and urethra (includes condyloma acuminate, giant perineal condyloma, and verrucous carcinoma), vulvar, lesions, polyps, and familiar polyps of the colon. Gynecology: Treatment of: Cervical intraepithelial neoplasia (CIN), herpes simplex, endometrial adhesions, cysts, and condyloma. Oral/Maxiofacial: Treatment of: Benign oral tumors, oral and glossal lesions, and gingivectomy. Otothrynolaringology / Head and Neck (ENT): Treatment of: Ear, nose and throat lesions, polyns, cysts, hyperkeratosis, Excision of carcinogenic tissue and oral leukoplakia. Ophthalmology : Treatment of: Soft tissue surrounding the eye and orbit. Podiatry: Treatment of: Warts, plantar verrucae, large mosaic verrucae, Matrixectomy. Clear Lift Pro Q-Switched Cr: Nd: YAG 1064 / 532 nm Applicator 1064mm mode is indicated for the removal or lightening of unwanted facial or body hair, for skin resurfacing (ablation of epidermal skin layers) in dermatology and aesthetic surgery, benign pigmented lesions (dermal melanocytosis) and tattoo removal for dark and blue inks. 532 nm mode is indicated for tattoo removal including red, blue and green inks, for the treatment of benign vascular lesions including telangiectasias, spider angiomas, spider nevi and the treatment of benign pigmented lesions including Café-au-lait birthmarks, solar lentigines, Becker's nevi, freckles nevus spilus and nevus of ota. 532mm mode is also indicated for incision, ablation and vaporization of soft tissue in general dermatology. ClearVas Nd:YAG 1064nm For the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stams, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg veins, and spider veins. Treatment of wrinkles. Removal of unwanted hair and for the treatment of pseudofolliculitis barbae (PFB). The ClearVas Nd: YAG 1064nm is indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin. Iris VL / PL Applicator: Intended for use in aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery, and dermatology. The treatment of benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, and ephelides (freckles), lentigines, nevi, melasma, and cafe-au-lait macules. The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas, poikiloderma of Civatte, leg veins and venous malformations. Use on all skin types (Fitzpatrick I- VI). Iris Dye VL / Dye SVL Applicator: The treatment of benign pigmented lesions including café -au-lait (macules), lentigines (senile and solar), freckles (ephelides), chloasma, nevi, nevus of Ota, and Becker's Nevi. • The treatment of other pigmented cutaneous lesions including verrucae, skin tags, keratosis, and plaques. • The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations. • Use on skin types (Fitzpatrick I-V). Iris SHR Applicator: The Advanced Fluorescence Technology (AFT) 650-950 nm handpiece (with and without contact-cooling) is indicated for: The treatment of tattoos, the treatment of moderate inflammatory acne vulgaris, the treatment of benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, and ephelides (freckles), lentigines, nevi, melasma, and cafe-au-lait, the treatment of cutaneous lesions including warts, scars and striae, the treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations. The removal of unwanted hair and to effect stable long-term or permanent hair reduction. Use on all skin types (Fitzpatrick I-VI), including tanned skin Iris Acne Applicator: Intended for use in aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical special and plastic surgery and dermatology. The Advanced Fluorescence Technology (AFT) 420-950 nm Acne Module Applicator (with and without contact-cooling) is indicated for: The treatment of moderate inflammatory acne vulgaris. The treatment of benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, and ephelides (freckles). The treatment of cutaneous lesions including warts, scars and striae. The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas, poikiloderma of Civate, leg veins and venous malformations. Use on all skin types (Fitzpatrick I-VI). Iris NIR Applicator: Intended to emit energy in the infra-red spectrum to provide topical heating for the purpose of elevating the tissue temperature. For the temporary relief of minor muscle 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. Iris Diode Applicator The Iris diode is intended for use for vascular lesions, spider naevi, teleangiectass, red superficial veins of the legs and face, pigmented lesions (e.g. cafe-au-lait stains, lentigo), hemangiomas, port wine stains, rosacea.

The Alma Harmony is a Class II Medical Device that combines multiple technologies into one platform for use in dermatologic, aesthetic procedures and pain management procedures. The system is comprised of a micro-processor-controlled and user-friendly console that houses the power supply, the electronics, and the user interface. It has 10 applicators that are attached to the console, which can be selected for use in treatment through the user interface. In addition, this submission will add the Smart Clinic Software that was previously cleared in the Soprano Titanium (K210371).

Intended for use in aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical special and plastic surgery, and dermatology. The treatment of benign pigmented epidermal lesions including dyschromia. hyperpigmentation, melasma, and ephelides (freckles), lentigines, nevi, melasma, and cafe-au-lait macules. The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas, poikiloderma of Civatte, leg veins and venous malformations. Use on all skin types (Fitzpatrick I- VI). The treatment of benign pigmented lesions including café -au-lait (macules), lentigines (senile and solar), freckles (ephelides), chloasma, nevi, nevus of Ota, and Becker's Nevi. • The treatment of other pigmented cutaneous lesions including verrucae, skin tags, keratosis, and plaques. • The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations. • Use on skin types (Fitzpatrick I-V). The Advanced Fluorescence Technology (AFT) 650-950 nm handpiece (with and without contact-cooling) is indicated for: The treatment of tattoos, the treatment of moderate inflammatory acne vulgaris, the treatment of benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, and ephelides (freckles), lentigines, nevi, melasma, and cafe-au-lait, the treatment of cutaneous lesions including warts, scars and striae, the treatments vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations. The removal of unwanted hair and to effect stable long-term or permanent hair reduction. Use on all skin types (Fitzpatrick I-VI), including tanned skin Intended for use in aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical special and plastic surgery and dermatology The Advanced Fluorescence Technology (AFT) 420-950 nm Acne Module Applicator (with and without contact-cooling) is indicated for: The treatment of moderate inflammatory acne vulgaris. The treatment of benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, and ephelides (freckles). The treatment of cutaneous lesions including warts, scars and striae. The treatment of 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. Use on all skin types (Fitzpatrick I-VI). Intended to emit energy in the infra-red spectrum to provide topical heating for the purpose of elevating the tissue temperature. For the temporary relief of minor muscle 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 Iris diode is intended for use for vascular lessons, spider naevi, teleangiectasis, red superficial veins o fthe legs and face, pigmented lesions (e.g. cafe-au-lait stains, lentigo), hemangiomas, port wine stains, rosacea.

The Alma Harmony is a Class II Medical Device that combines multiple technologies into one platform for use in dermatologic, aesthetic procedures and pain management procedures. The system is comprised of a micro-processor-controlled and user-friendly console that houses the power supply, the electronics and the user interface. It has 6 applicators that are attached to the console, which can be selected for use in treatment through the user interface. There are 6 separate applicators. Each handpiece has its own indication for use. - Iris VL / PL is an IPL handpiece operating in the wavelength range of 540nm-950nm ● - Iris Dye VL and Dye SVL is an IPL handpiece operating in the wavelength range of ● 500nm-600nm - Iris SHR is an IPL handpiece that operates in the wavelength range of 650nm-950nm - Iris Acne is an IPL handpiece operating in the wavelength range of 420nm 950nm ● - Iris NIR is near infrared with a wavelength of 1300nm ● - Iris Diode is a 520nm diode laser.

The Alma Lasers Family of Soprano XL Multi-Application Platforms is intended for use in dermatologic and general surgical procedures. The Alma Lasers Modified Diode Laser Module (used with the Alma Lasers Family of Soprano XL Multi-Application Platforms): - The HR Mode is intended for hair removal, permanent hair reduction. . - . The SHR Mode is intended for hair removal, permanent hair reduction. - The LaserBlanche Mode is intended for the treatment of benign vascular and pigmented . lesions. The Alma Lasers Family of Soprano XL Multi-Application Platforms is intended for use on all skin types (Fitzpatrick skin types I-VI), including tanned skin.

The Alma Lasers Modified Diode Laser Module with SHR Treatment Mode for use with the Family of Soprano XL Multi-Application Platforms, and the delivery accessories that are used with it, is comprised of the following main components: - A module housing with: . - Module trigger switch (must be pressed at the same time the Soprano system A footswitch is depressed to deliver laser energy to the treatment site); - A Light guide - TEC-cooled to provide contact skin cooling 9 - A Light guide retainer - Umbilical cable and connector that attaches the Diode Laser Module to the Soprano . system console and includes the electrical and cooling connections to the Soprano system.

The Modified Alma Lasers Family of Accent™ Radiofrequency (RF) Systems [Accent, Accent XL, Accent Elite] is intended for use in dermatologic and general surgical procedures. The Alma Lasers Family of Accent™ RF Systems [Accent XL, Accent Elite] is indicated for the non-invasive treatment of wrinkles and rhytids using a combined treatment with unipolar and bipolar handpieces. The massager component of the Alma Lasers Accent UniForm Handpiece is intended for use with the Modified Alma Lasers Family of Accent™ RF Systems [Accent, Accent XL, Accent Elite] to provide: Temporary reduction in the appearance of cellulite. . Simultaneous application of the RF energy and mechanical manipulation of the skin is intended for use with the Modified Alma Lasers Family of Accent™ RF Systems [Accent, Accent XL, Accent Elite] to provide: Temporary reduction in the appearance of cellulite. .

The Alma Lasers Accent Elite system similar to Accent™ RF Systems [Accent, Accent XL } is comprised of the following main components: . Console a Bipolar RF module A Unipolar RF module (UniLarge) A UniForm (RF and Massage) module . Control panel Footswitch. . Modules are used to deliver radiofrequency energy to the treatment site. Each RF module consists of the following components: . Handle - used for holding the module . Trigger - activates the radiofrequency energy emission when pressed in Ready mode Applicator tip establishes contact with the patient's skin . . Thermoelectric cooler - integrated within the module, provides internal module cooling . RF emission indicator - blue LED illuminates prior to- and during RF emission Umbilical cable contains coolant tubes. RF-power cable and the communication . cable that controls the operation of the module . Module connector - connects the module to its port. It incorporates an integrated impedance matching network (IMN) and a memory chip which stores information about the module and the parameter settings. The UniForm module additionally employs a massaging mechanism that works in conjunction with the RF energy application. The Accent Elite is a computerized system with embedded software that controls its operation. The software also runs the graphical user interface, which enables user-friendly control of the system operation.

The Alma Lasers Pixel CO2™ Laser System, Delivery Devices and 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 (knee). The Alma Lasers Pixel CO2™ Laser System is cleared 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. Laser skin resurfacing (ablation and/or vaporization) of soft tissue for the reduction, removal, and/or treatment of: keratoses, including actinic and seborrheic keratosis, seborrhoecae vulgares, seborrheic wart, and verruca seborrheica; vermillionectomy of the lip; cutaneous horns; solar/actinic elastosis; 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; 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 matrixectomy. 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 of soft tissue for the creation of recipient sites for hair transplantation. Podiatry: Laser ablation, vaporization and for 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; laser/tumor surgery in the larynx, pharynx, nasal, ear and oral structures and tissue; Zenker's Diverticulum/pharyngoesophageal diverticulum [endoscopic 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, tracheobronchial/endobronchial); benign and malignant lesions and fibromas (nose and nasal passages); benign and malignant tumors and fibromas; (oral); stapedotomy/stapedectomy; acoustic neuroma in the ear; superficial lesions of the ear, including chondrodermatitis nondularis chronica helices/Winkler's disease; telangiectasia/hemangioma of larynx, pharynx and trachea (includes uvula, palatal or upper lateral pharyngeal tissue); cordectomy, cordotomy (for the treatment of vocal fold paralysis/vocal fold motion impairment), and cordal lesions of larynx, pharynx and trachea; myringotomy/tympanostomy (tympanic membrane fenestration); uvulopalatoplasty (LAUP, laser UPPP); turbinectomy and turbinate reduction/ablation); septal spur ablation/reduction and septoplasty; partial glossectomy; tumor resection on oral, subfacial and neck tissues; rhinophyma; verrucae vulgares (warts); gingivoplasty/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, perineal, and Bowen's disease, (Erythroplasia of Queyrat) and Bowenoid papulosa (BP) lesions; leukoplakia (vulvar dystrophies); incision and drainage (I&D) of Bartholin's and nubuthian cysts; herpes vaporization; urethral caruncle vaporization; cervical dysplasia; benign and malignant tumors; hemangiomas. GYN Laparoscopy: Vaporization, incision, excision, ablation, or photocoagulation of soft tissue in endoscopic and laparoscopic surgery, including GYN laparoscopy, for treatment of: endometrial lesions, including ablation of endometriosis; excision/lysis of adhesions; salpingostomy; oophorectomy/ovariectomy; fimbroplasty; metroplasty; microsurgery (tubal); uterine myomas and fibroids; ovarian fibromas and follicle cysts; uterosacral ligament ablation; hysterectomy. Neurosurgery: Laser incision, excision, ablation and/or vaporization 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; reduction mammoplasty; cytoreduction for metastatic disease; laparotomy and laparoscopic applications; mediastinal and thoracic lesions and abnormalities; skin tag vaporization; atheroma; cysts, including sebaceous cysts, pilar cysts, and mucous cysts of the lips; pilonidal cyst removal and repair; abscesses; other soft tissue applications. Dental/Oral Surgery: Incision/excision and vaporization of soft tissue in dentistry and oral surgery. Applications include: gingivectomy- removal of hyperplasias; gingivoplasty; incisional and excisional biopsy; treatment of ulcerous lesions, including aphthous ulcers; incision of infection when used with antibiotic therapy; frenectomy (frenum release); excision and ablation of benign and malignant lesions; homeostasis; operculectomy; crown lengthening; removal of soft tissue, cysts and tumors; oral cavity tumors and hemangiomas; abscesses; extraction site hemostasis; salivary gland pathologies; preprosthetic gum preparation; leukoplakia; partial glossectomy; periodontal gum resection. Genitourinary: Incision/excision and vaporization and of soft tissue in genitourinary procedures. Applications include: benign and malignant lesions of external genitalia; condyloma; phimosis; erythroplasia.

The Alma Lasers Pixel CO2™ Laser System, Delivery Devices and Accessories are used to deliver light energy and are intended for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in the medical specialties, including: aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (ENT), gynecology, neurosurgery, orthopedics (soft tissue), arthroscopy (knee), general and thoracic surgery (including open and endoscopic), oral surgery and genitourinary surgery. The Alma Lasers Pixel CO2™ CO2 Laser System consists of the following major components: 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), LCD control panel with touch-screen technology, 7-joint articulated arm, Footswitch, Delivery Device Handpieces: Focusing handpieces, Pixel handpieces.

The Modified Alma Lasers Family of SOPRANO XL™ Multi-Application Platforms [Soprano XL, Soprano XLi] is intended for use in dermatologic and general surgical procedures. The Alma Lasers Family of SOPRANO XL™ Multi-Application Platforms [Soprano XLi] 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 Modified Alma Lasers Family of Soprano™ Diode Laser Systems [Soprano XL, Soprano XLi] is intended for use on all skin types (Fitzpatrick skin types I-VI), including tanned skin.

The Alma Lasers Soprano XLi system is a multi-application, multi-technology platform that supports the following technologies: - · Diode laser technology - · Near-infrared light technology (NIR) . The complete Soprano XLi platform consists of its console, two available module handpieces and a footswitch (refer to Figure 1). The module is pressed against the patient's skin and a light pulse is delivered when the handpiece trigger and/or the footswitch are activated. The handpiece tip is cooled to provide active and continuous skin cooling. 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.