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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).

This document is a 510(k) premarket notification for a medical device, the UltraPulse Surgical and Aesthetic CO2 Laser System. It is focused on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving a new medical claim or showing improved clinical effectiveness. Therefore, the typical elements of an AI/ML device study (like sample size for test/training, expert adjudication, MRMC studies, or specific performance metrics like sensitivity/specificity for a diagnostic algorithm) are not applicable here.

This submission is for a physical laser system (hardware and software that controls it), not for an AI/ML diagnostic or prognostic algorithm. The acceptance criteria and supporting studies are centered on compliance with safety standards and functional equivalence to its predicate, rather than clinical performance metrics.

Here's an analysis based on the provided document:

1. A table of acceptance criteria and the reported device performance:

Since this is a submission for a physical laser device and not a diagnostic AI/ML algorithm, the acceptance criteria are not typically presented in terms of clinical performance metrics like sensitivity, specificity, or AUC, as would be common for AI/ML. Instead, they are related to safety, functionality, and equivalence to the predicate device. The document describes the studies performed to verify these, rather than providing a quantitative table of achieved "performance" against acceptance criteria for a new clinical claim.

The document implicitly states that the "acceptance criteria" were met by showing that the modified device:

• Conformed to relevant electrical, laser, and electromagnetic compatibility safety standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1).
• Underwent software verification and validation according to IEC 62304 and FDA guidance.
• Passed system testing for basic functionalities (energy measurements, safety controls, emission indicator, scanners, aiming beam).
• Underwent usability assessment per FDA guidance and IEC standards.
• Evaluated changes to accessories, reprocessing, and biocompatibility.

The "reported device performance" is summarized as: "Test results indicated that the modified UltraPulse performs in accordance with its requirements and specifications similarly to its predicate UltraPulse System member of the Lumenis Family of UltraPulse SurgiTouch CO2 Surgical and Aesthetic Laser Systems."

2. Sample size used for the test set and the data provenance:

• Not applicable in the context of AI/ML diagnostic/prognostic models. For a physical device verification, "sample size" doesn't refer to a dataset of patient images/samples. Instead, it refers to the number of units tested, or the scope of testing performed according to engineering and quality assurance protocols. The document does not specify a numerical count of devices or components tested, but implies comprehensive testing of the modified system.
• Data Provenance: The data would be internally generated from engineering and quality assurance testing in Israel (Lumenis Ltd. is based in Yokneam, Israel) during the device development and verification process. It is neither retrospective nor prospective in the common sense of clinical studies with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. This submission is for a physical laser device, not an AI/ML system requiring expert-annotated ground truth for clinical decision support. The "ground truth" for this device's performance would be established by objective measurements and adherence to engineering specifications and safety standards, not by human expert consensus on clinical data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies to establish a consensus (ground truth) among multiple human readers for diagnostic tasks. This is irrelevant for a hardware/software system verification for substantial equivalence.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No. This is a hardware/software laser system, not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human reader performance with and without AI assistance was not conducted and is not relevant for this 510(k) submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable. This is a device that performs a physical action (laser ablation/vaporization). Its "performance" is inherent to its functional specifications and safety, not a standalone diagnostic algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• For physical device verification and validation, "ground truth" is established by:
  • Engineering specifications and design requirements: The device must perform as designed.
  • International standards: Adherence to electrical safety (e.g., IEC 60601-1), laser safety (e.g., IEC 60825-1), EMC (e.g., IEC 60601-1-2), and software development standards (e.g., IEC 62304).
  • Risk analysis (ISO 14971): Ensuring identified risks are mitigated.
  • Predicate device's established performance: The modified device must perform "similarly" to the cleared predicate.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML algorithm that requires a training set. The software for this device is likely developed using traditional software engineering paradigms, validated through testing, not "trained" on data.

9. How the ground truth for the training set was established:

• Not applicable. As above, no training set for an AI/ML model.

In summary, this 510(k) is about demonstrating the safety and effectiveness of a modified CO2 laser system through adherence to engineering standards, risk analysis, and substantial equivalence to a predicate device. It is not an AI/ML product seeking clearance based on diagnostic performance metrics.

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