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The Soprano Titanium diode laser module is intended for use in dermatology procedures requiring coagulation. The indications for use for the Soprano Trio diode laser module include: The Super Hair Removal (SHR) Mode is intended for temporary hair reduction. The Soprano Trio diode laser module HR mode is intended for use in dermatology procedures requiring coagulation. The indications for the Soprano Trio diode laser HR module include: Benign vascular and vascular dependent lesions. 810nm Applicator Soprano Titanium 810 nm applicator intended use and indications for use: The indications for use for the 810nm Modified Diode Laser Module 2 cm2 include: • The Hair Removal (HR) and Super Hair Removal (SHR) Mode are 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) 755nm applicator Soprano Titanium 755 nm applicator intended use and indications for use: The indications for use for the 755nm Diode Laser Module include: • The Hair Removal (HR) and Super Hair Removal (SHR) Mode are 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, SHR Modes) NIR Applicator NIR Applicator intended use and indications for use 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 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 Soprano Titanium 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) - 810 nm applicator ● - 755 nm applicator - Small NIR applicator - Trio 4 cm2 applicator ● - Trio 2 cm2applicator .

The Soprano Titanium diode laser module is intended for use in dermatology procedures requiring coagulation. The indications for use for the Soprano Trio diode laser module include: The Super Hair Removal (SHR) Mode is intended for temporary hair reduction. The Soprano Trio diode laser module HR mode is intended for use in dermatology procedures requiring coagulation. The indications for use for the Soprano Trio diode include: Benign vascular and vascular dependent lesions. 810nm Applicator: The Hair Removal (HR) and Super Hair Removal (SHR) Mode are 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) 755nm applicator: The Hair Removal (HR) and Super Hair Removal (SHR) Mode are 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, SHR Modes) NIR Applicator: 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 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 Soprano Titanium 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), Trio applicator with 1064 nm, 810 nm and 755 nm wavelengths applied simultaneously, 810 nm applicator, 755 nm applicator, Small NIR applicator, Footswitch and other laser safety accessories.

The Alma Lasers Family of Accent RF Systems [Accent XL, Accent Elite, and Opus] is intended for use in dermatologic and general surgical procedures. The Opus Plasma Applicator and Tips - The Opus Plasma Tips (Focus and Glide), when used with the unipolar applicator, are indicated for dermatological procedures requiring ablation and resurfacing of the skin. The Opus Colibri Applicator and Tips The Opus Colibri Tips, when used with the unipolar Opus Collbri applicator, are indicated for dermatological procedures requiring resurfacing of the skin.

The new Colibri handpiece with two tips incorporates the unipolar RF-based technology and delivers radiofrequency energy via the designed tips that creates micro-plasma causing controlled ablation micro-perforations and a thermal injury zone in the skin, surrounding the perforations. The new Colibri RF fractional tips are made of the same material as the existing cleared RF tips. The purpose of the Colibri tips is to treat very small areas of skin.

The Dye VL Handpiece (500-600 nm) is indicated for: - The treatment of benign pigmented lesions including café -au-lait (macules), lentigines (senile and solar), freckles (ephelides), chloasma, nevi, nevus spillus, 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, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations. - Use on skin types (Fitzpatrick I-V).

The Harmony XL™ continues to be comprised of the identical console unit, footswitch, and a variety of handpieces. The main console of the Harmony XL™ continues to consist of the same control panel, system controller, power supply modules, cooling system, switching module, and isolation transformer. The subject change is to add a version of the 515-950 nm SVL515 Module AFT handpiece ("SVL515") provided in the company's cleared Harmony XL™ (K072564) to the Harmony XL™ system. The modified handpiece has a narrowed wavelength range of 500-600 nm as compared to the SVL515 handpiece that has a wavelength of 515-950 nm. In addition, the modified handpiece is named the "Dye VL handpiece." Further, the identification color of the distal end of the handpiece is being changed from turquoise to light green.

Intended Use: The device is intended for use in dermatologic and general surgical procedures. Indications for Use: The Soprano trio Diode Laser Module is intended for use in dermatology procedures requiring coagulation. The indications for use for the Soprano Trio Diode Laser Module include: - Benign vascular and vascular dependent lesions removal. The indications for use for the Soprano1064nm Diode Laser Module include: - The Hair Removal (HR) and Super Hair Removal (SHR) Mode are 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. - Treatment of Pseudo folliculitis Barbae (PFB) - Use on all skin types (Fitzpatrick I-VI), including tanned skin. The indications for use for the 810nm Modified Diode Laser Module 1.2 cm' include: - . The Hair Removal (HR) and Super Hair Removal (SHR) Mode are 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 cm include: - The Hair Removal (HR) and Super Hair Removal (SHR) Mode are 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 are 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) - 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, - . 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 minor muscular back pain.

The subject device, Alma Lasers Soprano Trio Diode Laser Module is an additional hand piece intended to be used with previously cleared Soprano platforms. Consistent with the previous clearance the system is intended to be used in user facilities such as hospitals, physicians' offices and medical spas, and its major components are still the main console unit, foot switch, and individual modules. No change has been made to the main console unit except for incorporation of the software needed to run the new module and adding a new device name (Soprano 100 Platinum) to the Soprano family name for marketing purposes. The footswitch and pre-existing modules are also unmodified from those cleared in K140009 and K170626. The module's operation involves emission of laser (diode) energy through the hand piece to the patient's skin. The materials that could contact the patient during device use are as cleared in the predicate. The device is re-usable and non-sterile; instructions for cleaning its components between uses are provided in the labeling.

The Alma LipoFlow System is used in the aspiration, harvesting, filtering and transferring of autologous adipose tissue and infiltration for aesthetic body contouring. If the harvested fat is to be re-implanted, the harvested fat is only to be used without any additional manipulation.

The Alma LipoFlow System is a wheeled cart (also called as console) that contains a peristaltic irrigation pump and an adjustable vacuum source. The peristaltic pump (120 VAC, 50-60 Hz and 220-230 VAC, 50-60 Hz) is intended for continuous and/or intermittent delivery of tumescent liquid into a patient's body. The vacuum source is a rocking piston oil-less pump that delivers an adjustable vacuum pressure intended for subsequent aspiration of localized subcutaneous fatty deposit. The console has a control panel that is the user interface for operating the system. The control panel has a peristaltic knob that allows a flow-rate selection of up to 535ml/min. The control panel also has a vacuum knob that allows the delivery of vacuum pressure of up to 27 in Hq (90 kPa). The device operates using a Peristaltic Pump Mode or a Vacuum Pump Mode. Only one mode can be activated at a time using the footswitch. The system also includes an AC Power Cord, isolation transformer, wires and connectors. Other third party components of the system include: canister-style filters, tubing, syringe for potential re-injection, infiltration cannulas, aspiration cannulas, HEPA filter tubing, tumescent tubing, suction canister holder and waste canisters, The canister filter (fat canister) is a closed loop tissue collection system with a volume capacity of up to 2500 mL. It includes a vacuum port, tissue port, tissue port and lid. It is used with the aspiration system to separate and filter adipose tissue for possible reimplantation. The aspiration system provides the vacuum suction source to the canister. As the tissue is harvested from the patient, it enters the canister via the collection port in the canister lid. The physician removes unwanted waste materials from the collection system via the vacuum port by closing the valve. This process leaves the fatty tissue that can be transferred to syringes via the tissue port for autologous fat re-injection.

Intended Use: The additional Soprano 1064nm Diode Laser Module is intended for use in dermatologic and general surgical procedures. Indications for Use: The indications for use for the Soprano1064nm Diode Laser Module include: - The Hair Removal (HR) and Super Hair Removal (SHR) Mode are 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. - Treatment of Pseudo folliculitis Barbae (PFB) - Use on all skin types (Fitzpatrick I-VI), including tanned skin.

The subject device, Alma Lasers Soprano 1064nm Diode Laser Module is an additional hand piece intended to be used with previously cleared Soprano 100 platform. Consistent with the previous clearance the system is intended to be used in user facilities such as hospitals, physicians' offices and medical spas, and its major components are still the main console unit, footswitch, and individual modules. No change has been made to the main console unit except for incorporation of the software needed to run the new module; the footswitch and pre-existing modules are also unmodified from those cleared in K140009. The module's operation involves emission of laser (diode) energy through the handpiece to the patient's skin. The materials that could contact the patient during device use are sapphire, aluminum, and plastic; these would all have limited-duration surface contact with intact skin. The device is re-usable and non-sterile; instructions for cleaning its components between uses are provided in the labeling.

The Modified Alma Lasers Family of Accent RF Systems [Accent XL, Accent Elite] is intended for use in dermatological 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 hand pieces. The massage component of the Alma Lasers Accent Uniform Hand piece 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 Unipolar and Bipolar hand pieces, when used as a combined treatment, are indicated for the non-invasive treatment of wrinkles and rhytids. The Pixel RF Tips (stationary and rolling), when used with the unipolar hand piece, are indicated for dermatological procedures requiring ablation and resurfacing of the skin. Ultrasound Module provides ultrasonic diathermy intended for: - Relief of pain - Muscle spasms - · Joint contractures - · NOT for the treatment of malignancies The hand pieces above are intended to be used with the console cleared in K101147 Alma Lasers Family of Accent RF Systems [Accent, Accent XL, Accent Elite].

The Alma Lasers Accent XL is a console with three previously cleared RF hand pieces and one ultrasound hand piece that is the subject of this submission. The previously cleared hand pieces have not changed from what was cleared in their associated 510(k) submissions. The new ultrasound hand piece is a therapeutic ultrasound hand piece with a frequency of 1 MHz using a 1.2 cm transducer. The touch screen on the console shows the treatments that have been chosen and when the output is active.

Intended Use: The Alma Lasers Family of Accent RF Systems [Accent XL, Accent Elite] is intended for use in dermatologic and general surgical procedures. Indications for Use: The Unipolar and Bipolar handpieces, when used as a combined treatment, are indicated for the non-invasive treatment of wrinkles and rhytids. The Pixel RF Tips (stationary and rolling), when used with the unipolar handpiece, are indicated for dermatological procedures requiring ablation and resurfacing of the skin.

The Accent Pixel RF Tips include cleanable, sterilizable, multiple use radiofrequency (RF) energy delivery devices (accessory) intended for use with the Alma Lasers Family of Accent™ RF Systems [Accent, Accent XL, Accent Elite]. These Pixel RF Tips are also available as single use, disposable products. The Accent Pixel RF Tips are comprised of the following main components: Pixel Stationary Tip, Pixel Roller Tip.

The Modified Alma Lasers Harmony 1064nm (Nd:YAG) Modules are intended to be used with the Harmony XL™ Multi-Application Platform for use in aesthetic, cosmetic, and surgical applications requiring the ablation, vaporization, excision, incision, and photothermolysis (photocoagulation or coagulation) of soft tissue in the medical specialties of dermatology, general and plastic surgery, endoscopic/laparoscopic surgery, gastroenterology, gynecology, otorhinolaryngology (ENT), general neurosurgery, oculoplastics, oral surgery, ophthalmology (skin around the eyes), orthopedics, podiatry, pulmonary/thoracic surgery, and urology for surgical and aesthetic applications. Indications for Use: Podiatry (ablation, vaporization, incision, excision, and coagulation of soft tissue) including: - Matrixectomy - Periungual and subungual warts - Plantar warts - Radical nail excision - Neuromas The Modified Alma Lasers Harmony 1064nm (Nd:YAG) Modules (Long Pulsed and Q-Switched) are intended for use with the Harmony XL™ Multi-Application Platform for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T mentagrophytes, and/or yeasts Candida albicans, etc.). The 1064 nm Nd:YAG Laser Module handpieces (Long Pulsed and Q-Switched with and without contact-cooling) are indicated for treatment and clearance of: - Benign vascular lesions such as, but not limited to treatment of: Port wine stains, Hemangiomas, Warts, Superficial and deep telangiectasias (venulectasias), Reticular veins (0.1-4.0 mm dia.) of the leg, Rosacea, Venus lake, Leg veins, Spider veins, Poikiloderma of Civatte, Angiomas - Benign cutaneous lesions, such as, but not limited to: Warts, Scars, Striae, Psoriasis - Benign pigmented lesions such as, but not limited to: Lentigos (age spots), Solar lentigos (sun spots), Cafe-au-lait macules, Seborrheic keratoses, Nevi and nevus of Ota, Chloasma, Verrucae, Skin tags, Keratoses, The removal of black, blue or green tattoos (significant reduction in the intensity of black and for blue/black tattoos), Plaques - Pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments. - The non-ablative treatment of facial wrinkles, such as, but not limited to: Periocular wrinkles, Perioral wrinkles - Laser skin resurfacing procedures for the treatment of: Acne scars, Wrinkles - Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. - Indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin. The 1064 nm Nd: YAG lasers (Long Pulsed only, with and without contact-cooling) is indicated for: - Removal of unwanted hair, for stable long-term, or permanent, hair reduction through selective targeting of melanin in hair follicles. - Removal or lightening of unwanted hair (with and without adjuvant preparation) - Treatment of pseudofolliculitis barbae (PFB)

The Modified Alma Lasers Harmony 1064nm (Nd:YAG) Modules for use in podiatry and for the temporary increase in clear nail in patients with onychomycosis is a laser handpiece that contains the optical bench that emits the high power Nd: YAG laser beam. The Modified Alma Lasers Harmony 1064nm (Nd: YAG) Modules are designed to be used with the Harmony XL™ Muli-Application Platform [Accent, Accent XL, Accent Beauty] for the delivery of long-pulse or O-switched laser energy. The patient contact portion of the Modified Alma Lasers Harmony 1064nm (Nd. YAG) Modules is a removable, cleanable, sterilizable stand-off tip. The Modified Alma Lasers Harmony 1064nm (Nd:YAG) Modules are comprised of the following main components: - Handpiece Housing - Incorporates the optical head (laser) - Handpiece trigger. - Standoff-Tip (cleanable/ sterilizable) - Laser emission indicator illuminates prior to- and during laser energy emission - Umbilical cable houses the wiring to the Harmony XLTM Muli-Application Platform - Module (handpiece) connector - connects the handpiece umbilical cable to its port on the Harmony XLTM Muli-Application Platform.