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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).

Lumenis AcuPulse W CO2 Laser System, Delivery Devices and Accessories is indicated for incision, ablation, vaporization and coagulation of body soft tissues in medical specialties including aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (ENT), gynaecology, neurosurgery, orthopaedics, general and thoracic surgery. The use with the scanning unit is indicated for ablative skin resurfacing.

The AcuPulse W system (recently cleared under K201663) is a scaled-down version of the cleared Lumenis Family of AcuPulse CO2Laser System. Delivery Devices and Accessories under K180597. The modified AcuPulse W, identically to its predicate (K201663) is comprised of the following main functional components: - 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 AcuPulse W and the cleared AcuPulse W (K201663) systems have the same proprietary software, which is embedded in the Main Controller, Peripheral Controller units and PC. Importantly, both systems use the same Software version, which was already validated, verified and submitted under K201663. Also, no changes to the Hardware were made to the svstem. The AcuPulse W is offered with previously cleared AcuPulse Handpieces/Tips that connect to the articulated arm or/and scanners for controlled delivery of laser energy to the target tissue. Among them, the cleared 90° Side-firing Handpiece (K201663) connects to the AcuScan 120 Microscanner through two adaptors (a Handpiece Adapter and Third Lens Adapter) for delivery of laser energy. The 90° Side-firing Handpiece is comprised of the following components: - . Handpiece Adapter (cleared under K201663) - . Tip: - Multiuse Standard Focus Tip (cleared under K201663) o - Multiuse Fine Focus Tip (cleared under (K201663) о - Disposable Standard Focus Tip (subject of this submission) o - Disposable Fine Focus Tip ((subject of this submission) o - . Limiter ring (cleared under K201663) In this submission, Lumenis is introducing a disposable configuration of the 90° Side-firing Handpiece Tips in addition to the already cleared multiuse tips to respond to the increased market demand of disposable accessories for reducing the occurrence of treatment acquired infections. These 90° Side-firing Handpiece disposable tips are single use tips, packaged and EO sterilized, similarly to Lumenis devices previously cleared and used with the cleared AcuPulse Family of CO2Lasers (K100384 and K130164).

Lumenis AcuPulse W CO2 Laser System, Delivery Devices and Accessories is indicated for incision, ablation, vaporization and coagulation of body soft tissues in medical specialties including aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (ENT), gynaecology, neurosurgery, orthopaedics, general and thoracic surgery. The use with the scanning unit is indicated for ablative skin resurfacing.

The subject AcuPulse W system is a new scaled-down version of the recently FDA cleared Lumenis AcuPulse CO2 Laser System, Delivery Devices and Accessories under K180597. It is based on the following hardware components in the AcuPulse: - . A Laser Console with a Free Beam Port to which an articulated arm attached. - Identical to the AcuPulse, the Laser Console of the AcuPulse W System houses the laser O tube and optical system, the laser power source, console electronics, laser output ports, cooling system, purge air pump, control components (including touch screen, emergency stop button) and rear connector panel. - . An articulated arm to guide laser output via a set of folding mirrors to the connected accessory for delivery of laser energy to the tissue. - . 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 AcuPulse and AcuPulse W systems have the same proprietary software, which is embedded in the Main Controller, Peripheral Controller units and PC. The differences between the two are the enabled or disabled software features, through a hardware key (HASP dongle), that reflects the capabilities of each laser system or the particular configuration of a given system. Importantly, both systems use the same Software version, which was already validated, verified and submitted under K180597. The AcuPulse W is offered with a subset of the previously cleared AcuPulse Handpieces/Tips that connect to the articulated arm or/and scanners for controlled delivery of laser energy to the target tissue. In addition, Lumenis is adding a Titanium (Ti-6Al-4V) 90° Side-firing Handpiece design. Like the cleared handpieces, it has multiple uses. The 90° Side-firing handpiece connects to the cleared AcuScan 120 Microscanner through two adaptors (a Handpiece Adapter and Third Lens Adapter) for delivery of laser energy. The 90° Side-firing handpiece is comprised of the following components: - Handpiece Adapter - Tip (Standard or Fine) - . Limiter ring (Standard or Fine) This handpiece is based on the same technology and principles of operation of the cleared CO2 delivery devices and its introduction does not raise any new questions of safety and/or efficacy.

The subject Stellar M22 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: - Benign epidermal lesions, including dyschromia, hyperpigmentation, melasma, and o ephelides (freckles) - Cutaneous lesions, including warts, scars and striae O - Benign cutaneous vascular lesions, including port wine stains, hemoangiomas, facial, O truncal and leg telangiectasias, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations - Removal of unwanted hair and to effect stable long term, or permanent* hair O reduction in skin types I-V through selective targeting of melanin in hair follicles - Mild to moderate inflammatory Acne (Acne vulgaris) o - The Nd:YAG Laser handpiece with a wavelength of 1064 nm (Multi-Spot Nd:YAG) is ● indicated for: - The coagulation and hemostasis of vascular lesions and soft tissue, including the O treatment and clearance of superficial and deep telangiectasias (venulectasias) and reticular veins (0.1-4.0 mm. diameter) of the leg - The removal of unwanted hair and to effect table long term, or permanent* hair O reduction in skin types I-V through selective targeting of melanin in hair follicles - The non-ablative treatment of facial wrinkles o - . ResurFX module and handpiece, with wavelength of 1565 nm, is indicated for: - Use in dermatological procedures requiring fractional skin resurfacing and O coagulation of soft tissue #### The Q-Switched Nd:YAG Laser Handpiece with a wavelength of 1064 nm is indicated ● for: - Removal of dark tattoos O - 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 subject Stellar M22 for Intense Pulsed Light (IPL) and Laser System is a multi-application, multitechnology platform with four (4) available treatment handpieces: - Stellar Intense Pulsed Light (IPL) handpiece; ● - . Multi-Spot Nd:YAG laser handpiece; - ResurFX non-ablative laser 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 530-650& 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 and metal treatment tips are available in seven (7) different sizes of: 2, 2.5, 3.5, 4, 5, 6 and 8 mm.

The Lumenis AcuPulse Family of CO2 Laser Systems, Delivery Devices and Accessories (AcuPulse, AcuPulse 40WG and AcuPulse DUO), 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 AcuPulse Family of CO2 Laser Systems, Delivery Devices and Accessories (AcuPulse, AcuPulse 40WG and AcuPulse DUO), 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, Neurosurgery, Orthopedics, General Surgery and Podiatry as follows: Dermatology Podiatry Otolaryngology (ENT) Gynecology and GYN Laparoscopy Indications Neurosurgery Indications Orthopedic Indication General and Thoracic Surgery Dental and Oral Surgery

The Lumenis AcuPulse Family of CO2 Laser Systems are advanced computer-controlled Carbon Dioxide (CO2) laser systems based on a DC-excited sealed-off CO2 laser tube, that depending on their configuration, can provide up to 30 or 40-Watts on tissue. The AcuPulse Family of CO2 Lasers includes the following system models: - The AcuPulse (previously called AcuPulse 30/40ST) system that incorporates a Free Beam Port only. - The AcuPulse 40WG System that incorporates a Fiber Port only. - The AcuPulse DUO, a new member of the family, which incorporates both a Free Beam Port and a Fiber Port. The AcuPulse DUO laser added to the AcuPulse family represents a combination of the previously cleared AcuPulse 30/40ST and AcuPulse 40WG lasers. The minor differences in technological characteristics between the AcuPulse DUO and the predicate systems exist to facilitate this integration (mechanical and software adaptations that enable having two ports in one System) and do not affect any of the device's functionalities or performance specifications. The AcuPulse DUO System, with the incorporation of both the Free Beam and the Fiber port in one console, shares the same underlying technology and fundamental functionality as the previously cleared AcuPulse Family of CO2 Laser Systems. All of these laser systems are comprised of the following main functional components: - a Laser Console with a port: a Free Beam Port to which an articulated arm is attached (AcuPulse model), a Fiber Port to which a Fiber is attached (AcuPulse 40WG), or both the Free Beam Port and Fiber Port (AcuPulse DUO) - a Footswitch - Various Free Beam Delivery Device and accessories (AcuPulse and AcuPulse DUO compatible) or Fiber Delivery Devices and accessories (AcuPulse 40WG and AcuPulse DUO compatible). The AcuPulse DUO, similarly to the previously cleared AcuPulse and AcuPulse 40WG, is operated and controlled via proprietary software embedded in the Main controller. Peripheral controller units and PC. The Delivery Devices and accessories, in accordance with their type and compatibility (e.g., Fiber Port or Free Beam port) are shared by all AcuPulse Laser Systems. The Free Beam Deliverv Devices and accessories include: Endoscopes/Laparoscopy accessories, Handpieces/Tips, Micromanipulators, and Scanners with accessories and adaptors. The Fibers that may be used with the Fiber Port are supplied with various handpieces (through which the Fiber may be inserted for more convenient handling during surgical procedures) and additional accessories for Fiber maintenance and handling.

The LightSheer Family of Pulsed Diode Array Laser Systems (LightSheer Desire, LightSheer Desire Light and LightSheer Infinity) is indicated for use in surgical, aesthetic applications in the medical specialties of general and plastic surgery, and dermatology. The LightSheer Family of Pulsed Diode Array Laser Systems is intended for use on all skin types (Fitzpatrick skin types I - VI), including tanned skin. Specific indications for each system and handpiece combination are listed in the document and include: - Treatment of benign vascular lesions, including angiomas, telangiectasia and other benign vascular lesions and leg veins - Treatment of pseudofolliculitis barbae (PFB) - Hair removal, permanent hair reduction* - Treatment of benign pigmented lesions, including age spots, solar lentigines, cafe-au-lait spots, nevi of Ota/Ito, melasma, Becker's nevi and other benign pigmented lesions - Treatment of wrinkles *Permanent hair reduction is defined as the 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 regime.

The Lumenis LightSheer Family of Pulse Diode Array Laser Systems consists of four laser consoles that can be used with up to four different types of handpieces. The four laser consoles are: LightSheer Duet, LightSheer Infinity, LightSheer Desire, and LightSheer Desire Light. The laser consoles provide (1) a graphical user interface and software for control of the system, (2) the needed electronics to control and power the accessories, (3) handpiece connection port(s), (4) a vacuum pump (most models) and (5) cooling system. Handpieces can be divided into two categories, depending on the technology applied to the skin during treatment: high speed (HS) Handpieces with vacuum technology (HIT™) or ET, XC and LR Handpieces with cooling technology (ChillTip), available with different sized tips. Some handpieces are universal, supporting different ChillTip sizes within a single handpiece. In addition, these handpieces either deliver pulsed diode laser light with wavelengths ranging from 790 - 950nm (805nm nominal) or 1040-1080nm (1060nm nominal), depending on the diode array type. The same LightSheer Handpieces are compatible with multiple systems (such as the LightSheer Duet, LightSheer Infinity, LightSheer Desire, and LightSheer Desire Light), in which case they differ only in terms of the mechanical connection to the console.

The Lumenis Family of Holmium Surgical Lasers and Delivery Devices and Accessories (VersaPulse PowerSuite, Lumenis Pulse 30H, Lumenis Pulse 50H, Lumenis Pulse 60H, Lumenis Pulse 100H and Lumenis Pulse 120H) are intended for use in surgical procedures involving open, laparoscopic and endoscopic ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: urology; urinary lithotripsy; arthroscopy; discectomy; E.N.T. surgery; gynecological surgery; pulmonary surgery; gastroenterology surgery; dermatology and plastic surgery and general surgery. The Lumenis Family of Holmium Surgical Lasers and Delivery Devices and Accessories are indicated for use in the performance of specific surqical applications as follows: Urology . Endoscopic transurethral incision of the prostate (TUIP), bladder neck incision of the prostate (BNI), holmium laser ablation of the prostate (HoLAP), holmium laser enucleation of the prostate (HoLEP), holmium laser resection of the prostate (HoLRP), hemostasis, vaporization and excision for treatment of benign prostatic hypertrophy (BPH) . Open and endoscopic urological surgery (ablation, vaporization, incision, excision and coagulation of soft tissue) including treatment of: o bladder; O superficial and invasive bladder, urethral and ureteral tumors; O condvlomas: O lesions of external genitalia; O ureteral and penile hemangioma; O ureteral strictures; O bladder neck obstructions ● Urinary Lithotripsy including: o endoscopic fragmentation of urinary (urethral, ureteral, bladder and renal) calculi, including cystine, calcium oxalate, monohydrate and calcium oxalate dihydrate stones; o treatment of distal impacted fragments of steinstrasse when quide wires cannot be passed. Arthroscopy . Arthroscopy (ablation, excision and coagulation of soft and cartilaginous tissue) in various small and large joints of the body, excluding the spine, including: o meniscectomy: o plica removal; O ligament and tendon release; O contouring and sculpting of articular surfaces; O debridement of inflamed synovial tissue (synovectomy); O loose body debridement; O chondromalacia and tears; O lateral retinecular release; O capsulectomy in the knee; O chondroplasty in the knee; O chondrornalacia ablation. . Discectorny including: o percutaneous vaporization of the L4-5 and LS-SI lumbar discs of the vertebral spine; open and arthroscopic spine procedures; foraminotomy. General Surgery ● Open, laparoscopic, and endoscopic general surgery (vaporization, ablation, incision, and coagulation of soft tissue) including: o cholecystectomy; o lysis of adhesions; O appendectomy; O biopsy, pylorostenotomy, and removal of polyps of the sigmoid colon; O skin incision: O tissue dissection; O excision of external tumors and lesions; O complete or partial resection of internal organs, tumors and lesions; O mastectomy; O hepatectomy; O pancreatectomy; O splenectomy; O thyroidectomy; O parathyroidectomy; O herniorrhaphy; O tonsillectomy; O lymphadenectomy; O partial nephrectomy; O epilonidal cystectomy; O resection of lipoma; O debridement of decubitus ulcer; O hemorrhoids; O debridement of statis ulcer; o biopsy. ENT Surgery ● Endoscopic endonasal/ sinus surgery (ablation, vaporization, incision, and coagulation of soft tissue and cartilage) including: o partial turbinectomy; o ethmoidectomy; o polypectomy; o maxillary antrostomy; o frontal sinusotomy; o sphenoidotomy; O dacryocystorhinostomy (DCR); O functional endoscopic sinus surgery (FESS). Gynecological Surgery ● Open and laparoscopic gynecological surgery (ablation, vaporization, incision, excision, and coagulation of soft tissue). Gastroenterology Surgery ● Open and endoscopic gastroenterology surgery (ablation, vaporization, incision, excision, resection, coagulation and hemostasis, including: o gall bladder calculi; o Biliary /bile duct calculi; o benign and malignant neoplasm; o polyps; o colitis; O ulcers; O angiodysplasia; O hemorrhoids; O varices; o esophaqitis: O esophageal ulcer; O Mallory-Weiss tear; O gastric ulcer; O duodenal ulcer; o non-bleeding ulcer; O gastric erosions; O colorectal cancer; O gastritis; O bleeding tumors; O pancreatitis; o vascular malformations; O telangiectasia; O telangiectasia of the Osler-Weber-Renu disease. Pulmonary Surgery ● Open and endoscopic pulmonary surgery (cutting, ablation, vaporization, incision, excision and coagulation of soft tissue. Dermatology and plastic surgery . Incision, excision, resection, ablation, coagulation, hemostasis and vaporization of soft, mucosal, fatty and cartilaginous tissues, in therapeutic plastic, dermatologic and aesthetic surgical procedures, including: o scars; O tattoo removal; O vascular lesions; O port wine stains; O hemangioma; O telangiectasia of the face and leg; O rosacea; O corns; O papilloma; O basal cell carcinomas; O lesions of skin and subcutaneous tissue; O plantar warts: O periungual and subungual warts; O debridement of decubitus ulcer; O skin tag vaporization.

The Lumenis Family of Holmium Surgical Lasers and Delivery Devices and Accessories (also referred to as 'Lumenis Family of Holmium Surgical Lasers'), subject of this submission, is a family of single wavelength holmium (Ho:YAG) lasers manufactured by Lumenis Ltd. The family is composed of two main series; the VersaPulse PowerSuite series (VPPS) which includes the VersaPulse PowerSuite 20W, VersaPulse PowerSuite 30W, VersaPulse PowerSuite 45W, VersaPulse PowerSuite 60W, VersaPulse PowerSuite 80W and VersaPulse PowerSuite 100W, cleared under K011703, together with the VersaPulse P20 cleared under K100228, and the modern Lumenis Pulse series which includes the recently cleared Lumenis Pulse 120H system (K140388) and further expanded with the addition of the Lumenis Pulse 30H, Lumenis Pulse 50H, Lumenis Pulse 60H and Lumenis Pulse 100H, subjects of this submission. The modifications to the subject Lumenis Family of Holmium Surgical Lasers include addition of modernized family members as well as updates to existing systems. Mainly, the subject additional devices are basically similar to the previously cleared Lumenis Pulse 120H (LP120H, recently cleared under K140388). The modified Lumenis Pulse 30H, Lumenis Pulse 50H, Lumenis Pulse 60H and Lumenis Pulse 100H systems rely on the same fundamental underlying technology of the cited predicate systems with the laser power outputs similar to the previously cleared configurations of the VersaPulse PowerSuite series cleared under K011703. The subject device modifications involve both hardware (HW) and software (SW) elements, whereas the functional capabilities of the laser systems remain unaltered in both the modified and cleared systems. The Lumenis Lumenis Pulse 60H and 120H are provided with the Moses Mode, based on the wellknown Moses Effect, which limits the attenuation of holmium laser energy in the liquid environment, thus reducing dependency of the fiber positioning (i.e. distance) in respect to the target tissue. All other characteristics of the laser emission are maintained identical as in the cleared Regular Mode. All of the modified Lumenis Family of Holmium Surgical Lasers are solid state Single Wavelength (Holmium) surgical laser, comprised of the following functional components: - Laser Console - Dual or single pedal Footswitch - Variety of Fiber Optic Delivery Devices (fibers) and accessories - An integrated suction pump and accessories (Lumenis Pulse 120H and Lumenis Pulse 60H) The systems are operated and controlled via proprietary SW. The SW comprises embedded SW in the main and peripheral processors, and Graphical User Interface (GUI) application running on a Personnel Computer (PC).

The subject Lumenis M22 System 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: 1. The Intense Pulsed Light (IPL) handpiece with a spectrum of 400-1200nm (with 8 different filters) is indicated for: · Benign epidermal lesions, including dyschromia, hyperpigmentation, melasma, ephelides (freckles) and tattoos · 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) 2. The Nd: Y AG Laser handpiece with a wavelength of 1064 nm (Multi-Spot Nd: Y AG) 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 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 non-ablative treatment of facial wrinkles 3. ResurFX module and handpiece, with wavelength of 1565 pm, is indicated for: · Use in dermatological procedures requiring skin resurfacing and coagulation of soft tissue 4. The Q-Switched Nd:YAG Laser Handpiece with a wavelength of 1064nm is indicated for: - Removal of dark tattoos . - · Treatment of pigmented lesions *Note 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 regime.

The subject Lumenis M22 System is a multi-application, multi-technology platform with four (4) available treatment handpieces: - Universal Intense Pulsed Light (IPL) handpiece (K083733) . - Multi-Spot Nd:YAG laser handpiece (K083733) - ResurFX non-ablative laser handpiece (K130028) . - Q-Switched Nd: Y AG laser handpiece (K043173) ●

The VersaCut + Tissue Morcellator is intended for use under direct or endoscopic visualization for the morcellation and removal of dissected tissue during pelviscopic, laparascopic, percutaneous and open surgical procedures whenever access to the surgical site is limited.

The VersaCut + Tissue Morcellator system is a multiple-use electrosurgical cutting and aspiration device that provides rapid and efficient morcellation and removal of dissected tissue under direct or endoscopic visualization. The cutting action of the VersaCut + Tissue Morcellator is driven by the motor in the handpiece and the treatment site is accessed through the sheath of a nephroscope using the endoscope adapter as needed to keep the cutting blades in the field of view. The VersaCut + Tissue Morcellator is comprised of a main component as listed below: - · Control unit with aspiration pump - · Limited reuse, steam sterilizable handpieces (motor-body unit) with power cable - · Limited reuse, steam sterilizable cutting blade sets - · Reusable, steam sterilizable endoscope adapters - · Drainage tube, single use - · Reusable, multi-position, multi-staged footswitch with power cable - · Sterile, single use aspiration tubing - · Tissue collection kit components, single use - · Reusable sterilization tray, including cleaning brushes The VersaCut + Tissue Morcellator is provided cleaned and non sterile. Before use, the handpiece, blades set and the endoscope adapters are to be cleaned and sterilized.