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

Device Description

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.

AI/ML Overview

The provided text is a 510(k) summary for the Lumenis AcuPulse Family of CO2 Laser Systems. It describes the device, its intended use, and indicates that performance testing was conducted. However, it does not contain detailed information regarding specific acceptance criteria, reported device performance in those criteria, sample sizes, ground truth establishment, or any comparative effectiveness studies (MRMC or standalone algorithm studies) in the manner typically associated with clinical performance evaluation for AI/ML devices.

The document focuses on demonstrating substantial equivalence to a predicate device (AcuPulse 30/40ST and AcuPulse 40WG CO2 Lasers, K100415) based on:

Intended use and indications for use: These are stated to be the same as the predicate devices.
Principles of operation: Stated to be the same.
Technological characteristics: Stated to be "nearly identical," with "minor differences" related to combining capabilities of previously cleared devices.
Performance data: General statements about risk analysis, electrical and laser safety, electromagnetic compatibility testing, software verification and validation, and system testing to ensure compliance with specifications.

Given these limitations, I cannot provide a table of acceptance criteria, reported device performance, or details about clinical study specifics such as sample sizes, data provenance, expert ground truth, adjudication methods, or MRMC/standalone study results for AI.

Here's a breakdown of what can be extracted from the document based on your request, and where information is explicitly not present:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Reported Device Performance (as per document)
Risk Analysis	Performed (ISO 14971)
Electrical Safety	Conforms to AAMI/ANSI/IEC ES 60601-1
Laser Safety	Conforms to IEC 60825-1, IEC 60601-2-22
Electromagnetic Comp.	Conforms to IEC 60601-1-2
Software Verification	Performed
Software Validation	Performed
System Performance	Performs in compliance with specifications and requirements; performs as intended and comparably to predicate devices.

Missing Information: Specific quantitative acceptance criteria (e.g., specific thresholds for laser power output, pulse duration accuracy, beam quality, or safety interlock response times) are not detailed, nor are the precise numerical results of the performance tests against such criteria. The document states "performance in compliance with their specifications and requirements" but does not list those specifications.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not specified. The performance testing mentions "system testing" but does not refer to a clinical "test set" in the context of diagnostic or predictive performance metrics. The evaluation focuses on device functionality and safety.
Data Provenance (e.g., country of origin, retrospective/prospective): Not specified. The tests appear to be engineering/technical verification and validation rather than clinical data studies.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Number of Experts: Not applicable/Not specified. Ground truth in the context of clinical interpretation, as would be relevant for AI/ML devices, is not mentioned. The testing described relates to the laser system's technical specifications and safety.
Qualifications of Experts: Not applicable/Not specified.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable/Not specified. This information is relevant for studies involving human interpretation or challenging cases, which is not the type of study described here.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study: No. The document does not mention any clinical comparative effectiveness study involving human readers, with or without AI assistance. The device is a surgical laser system, not an AI diagnostic tool that would typically be evaluated with MRMC studies.
Effect Size of Human Readers with AI vs. without AI: Not applicable, as no such study was conducted or reported.

6. Standalone (Algorithm Only) Performance Study

Standalone Study: No. This device is a physical CO2 laser system, not an AI algorithm intended for standalone performance evaluation against a diagnostic problem. Performance testing was related to the physical and software functionality of the laser itself.

7. Type of Ground Truth Used

Type of Ground Truth: For the performance tests conducted (risk analysis, electrical/laser safety, EM compatibility, software V&V, system testing), the "ground truth" would be the engineering specifications, regulatory standards (e.g., IEC standards), and the device's design requirements. There is no mention of clinical ground truth (e.g., pathology, outcomes data, or expert consensus) as would be relevant for a diagnostic or prognostic device.

8. Sample Size for the Training Set

Sample Size for Training Set: Not applicable/Not specified. This concept is relevant for AI/ML models that learn from data. The document describes a traditional medical device (laser system) with embedded proprietary software, but not an AI/ML system with a "training set."

9. How the Ground Truth for the Training Set Was Established

How Ground Truth Was Established: Not applicable/Not specified. As there's no mention of an AI training set, this information is not relevant to the provided document.

In summary: The provided 510(k) summary is for a traditional surgical laser system. The "performance data" section focuses on engineering verification and validation against regulatory standards and internal specifications to demonstrate safety and effectiveness for substantial equivalence, rather than clinical performance evaluation of an AI/ML algorithm against a diagnostic ground truth. Therefore, many of the specific details requested regarding AI/ML study design are not present in this document.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

April 3, 2018

Lumenis Ltd. Amaya De Levie Head of Surgical Regulatory Affairs 6 Hakidma Street P O Box 240 Yokneam, 2069204 Il

Re: K180597

Trade/Device Name: AcuPulse (previously called AcuPulse 30/40 ST); AcuPulse 40W G; AcuPulse DUO Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology Regulatory Class: Class II Product Code: GEX Dated: March 6, 2018 Received: March 6, 2018

Dear Amaya De Levie:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely, Jennifer R. Stevenson -53 For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K180597

Device Name

The Lumenis AcuPulse Family of CO2 Laser Systems, Delivery Devices and Accessories (AcuPulse, AcuPulse DUO)

Indications for Use (Describe)

Intended Use/ Indications for Use:

The Lumenis AcuPulse Family of CO2 Laser Systems, Delivery Devices and Accessories (AcuPulse, AcuPulse 40WG and AcuPulse DUO), is indicated for the vaporization, incision, 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, 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

The Lumenis AcuPulse Family of CO2 Laser Systems, Delivery Devices and Accessories (AcuPulse 40WG and AcuPulse DUO), is indicated for use in dermatology and plastic surgery for the following applications:

· Ablation, vaporization, excision, incision and coagulation of soft tissue in the performance of:
Laser skin resurfacing
Laser dermabrasion
Laser burn debridement
· Laser skin resurfacing (ablation and/or vaporization) for the 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:
Keratosis, 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

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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/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

The Lumenis AcuPulse Family of CO2 Laser Systems, Delivery Devices and Accessories (AcuPulse, AcuPulse 40WG and AcuPulse DUO), is indicated for the following applications:

· Laser ablation, vaporization, and/or excision of soft tissue for the reduction, removal, and/or treatment of:
Verrucae vulgares/plantar (warts), including paronychial, periungal and subungual warts
Fungal nail treatment
Porokeratoma ablation
Ingrown nail treatment
Neuromas/fibromas, including Morton's neuroma
Debridement of ulcers
Other soft tissue lesions
· Laser ablation, vaporization, and/or excision for complete and partial (nail) matrixectomy

Otolaryngology (ENT)

The Lumenis AcuPulse Family of CO2 Laser Systems, Delivery Devices and Accessories (AcuPulse, AcuPulse 40WG and AcuPulse DUO), is indicated for laser incision, 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 nodularis chronica helices/Winkler's disease

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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 and GYN Laparoscopy Indications

The Lumenis AcuPulse Family of CO2 Laser Systems, Delivery Devices and Accessories (AcuPulse, AcuPulse 40WG and AcuPulse DUO), is indicated for the following applications:

· 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 Bowenoid papulosa (BP lesions)
Leukoplakia (vulvar dystrophies)
Incision and drainage (I&D) of Bartholin's and nabothian cysts
Herpes vaporization
Urethral caruncle vaporization
Cervical dysplasia
Benign and malignant tumors
Hemangiomas

· Vaporization, incision, 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
Fimbrioplasty
Metroplasty
Microsurgery (tubal)
Uterine myomas and fibroids
Ovarian fibromas and follicle cysts
Uterosacral ligament ablation
Hysterectomy

Neurosurgery Indications

· 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

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Intra and extradural lesions
Laminectomy/laminotomy/microdiscectomy

Orthopedic Indication

The Lumenis AcuPulse Family of CO2 Laser Systems, Delivery Devices and Accessories (AcuPulse, AcuPulse 40WG and AcuPulse DUO), is indicated for incision, excision and vaporization of soft tissue in orthopedic surgery, including the following applications:

Arthroscopy
Meniscectomy
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

The Lumenis AcuPulse Family of CO2 Laser Systems, Delivery Devices and Accessories (AcuPulse, AcuPulse 40WG and AcuPulse DUO), is indicated for the incision, excision of soft tissue in general and thoracy 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

· 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

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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

Type of Use (Select one or both, as applicable)

ال Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY

The Lumenis AcuPulse Family of CQ2 Laser Systems, Delivery Devices and Accessories

Applicant Name:	Lumenis Ltd.6 Hakidma Street PO Box 240Yokneam Industrial Park,Yokneam 2069204, IsraelTel: +972-4-9599000Fax: +972-4-9599046
Contact Person:	Amaya De Levie Lumenis Ltd.6 Hakidma Street PO Box 240,Yokneam Industrial Park,Yokneam 2069204, IsraelTel:+972-4-9599119Fax +972-4-9599198email:amaya.de-levie@lumenis.com
Date Prepared:	06 March 2018
Trade Name:	Lumenis AcuPulse Family of CO2 Laser Systems, Delivery Devices andAccessories (AcuPulse, AcuPulse 40WG and AcuPulse DUO)
Classification Name:	Powered laser surgical instrument
Product Code:	GEX
Device Class:	Class II
Regulation Number:	21 C.F.R. § 878.4810
Panel:	General & Plastic Surgery
Predicate Device:	AcuPulse 30/40ST and AcuPulse 40WG CO2 Lasers (K100415)

Intended Use/ Indications for Use:

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including GYN Laparoscopy, Aesthetic Surgery, Dental and Oral Surgery, Neurosurgery, Orthopedics, General Surgery and Podiatry as follows:

Dermatology

The Lumenis AcuPulse Family of CO2 Laser Systems, Delivery Devices and Accessories (AcuPulse, AcuPulse 40WG and AcuPulse DUO), is indicated for use in dermatology and plastic surgery for the following applications:

. Ablation, vaporization, excision, incision and coagulation of soft tissue in the performance of:
- Laser skin resurfacing
- Laser dermabrasion
- Laser burn debridement
- Laser skin resurfacing (ablation and/or vaporization) for the 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:
- Keratosis, including actinic and seborrheic keratosis, seborrhoea vulgares, seborrheic wart and verruca seborrheica.
- Vermillionectomy of the lip
- Cutaneous horns
- Solar/actinic elastosis ı
- 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 granulomas/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)
- Debridement of eczematous or infected skin .
- Basal and squamous cell carcinoma, including keratoacanthomas, Bowen's disease i (Erythroplasia of Queyrat), and Bowenoid Papulosis (BP) lesions
- Nevi, including spider, epidermal and protruding -
- Neurofibromas i

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Laser de-epithelialization
Tricoepitheliomas
Xanthelasma palpebrarum
Syringoma
Laser ablation, vaporization, and/or excision for complete and partial nail matrixectomy
Vaporization or coaqulation of: ●
- Benign/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

The Lumenis AcuPulse Family of CO2 Laser Systems, Delivery Devices and Accessories (AcuPulse, AcuPulse 40WG and AcuPulse DUO), is indicated for use in podiatry for the following applications:

Laser ablation, vaporization, and/or excision of soft tissue for the reduction, removal, . and/or treatment of:
- Verrucae vulgares/plantar (warts), including paronychial, periungal and subungual warts
- Fungal nail treatment
- Porokeratoma ablation i
- -Ingrown nail treatment
- Neuromas/fibromas, including Morton's neuroma -
- Debridement of ulcers -
- Other soft tissue lesions i
Laser ablation, vaporization, and/or excision for complete and partial (nail) matrixectomy .

Otolaryngology (ENT)

The Lumenis AcuPulse Family of CO2 Laser Systems, Delivery Devices and Accessories (AcuPulse, AcuPulse 40WG and AcuPulse DUO), is indicated for 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 ●

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. 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 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, 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 nodularis chronica helices/Winkler's disease
. Telangiectasia/hemangioma of larynx, pharynx and trachea (includes uvula, palatal, or upper lateral pharyngeal tissue)
Cordectorny, 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 and GYN Laparoscopy Indications

The Lumenis AcuPulse Family of CO2 Laser Systems, Delivery Devices and Accessories (AcuPulse, AcuPulse 40WG and AcuPulse DUO), is indicated for use in gynecology for the following applications:

. 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 vaqinal intraepithelial neoplasia (VIN, VAIN)

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i Condyloma acuminata, including cervical, genital, vulvar, perineal, and Bowenoid papulosa (BP lesions)
Leukoplakia (vulvar dystrophies)
Incision and drainage (I&D) of Bartholin's and nabothian cysts ।
Herpes vaporization
Urethral caruncle vaporization
Cervical dysplasia
Benign and malignant tumors i
Hemangiomas
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
- i Fimbrioplasty
- Microsurgery (tubal)
- Uterine myomas and fibroids
- Ovarian fibromas and follicle cysts -
- Uterosacral ligament ablation
- Hysterectomy

Neurosurgery Indications

. Cranial
- i 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 Indication

The Lumenis AcuPulse Family of CO2 Laser Systems, Delivery Devices and Accessories (AcuPulse, AcuPulse 40WG and AcuPulse DUO), is indicated for incision, excision and

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vaporization of soft tissue in orthopedic surgery, including the following applications:

. Arthroscopy
- Meniscectomy
- Chondromalacia
- Chondroplasty
- Ligament release (lateral and other)
- Excision of plica i
- Partial synovectomy i
. General
- Debridement of traumatic wounds i
- Debridement of decubitus and diabetic ulcers
- Microsurgery i
- Artificial joint revision
- PMMA removal -

General and Thoracic Surgery

The Lumenis AcuPulse Family of CO2 Laser Systems, Delivery Devices and Accessories (AcuPulse, AcuPulse 40WG and AcuPulse DUO), is indicated for the 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

Gingivectomy/removal of hyperplasias
. Gingivoplasty

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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 qum preparation ●
Leukoplakia
Partial glossectomy ●
Periodontal qum resection ●

Device Description / Summary of Technological Characteristics:

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.

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 ●

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. 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.

Performance Data

Performance testing was conducted in order to demonstrate the performance of the modified AcuPulse Family of CO2 Laser Systems, Delivery Devices, and Accessories and to verify that no different questions of safety and effectiveness have been raised due to the modifications introduced. The following activities were performed:

. Risk analysis (ISO 14971)
. Electrical and laser safety and electromagnetic compatibility testing as required to conform to recognized performance standards as follows:
- AAMI/ANSI/IEC ES 60601-1, Medical electrical equipment Part 1: General O requirements for basic safety and essential performance
- IEC 60601-1-2: Medical electrical equipment Part 1-2: General requirements о for basic safety and essential performance - Collateral standard: Electromagnetic compatibility- requirements and tests
- IEC 60825-1: Safety of laser products Part 1: Equipment classification and o requirements
- IEC 60601-2-22: Medical electrical equipment Part 2-22: particular o requirements for the safety of diagnostic and therapeutic laser equipment.
. Software verification and validation
System testing demonstrating that the systems perform in compliance with their ● specifications and requirements

Test results indicated that the modified components of the AcuPulse Family of CO2 Laser Systems. Delivery Devices, and Accessories perform in accordance with its requirements and specifications, which are derived from those of the cleared predicate device.

1 The fiber accessories are cleared under K100384 and K130164

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Conclusions

The modified AcuPulse Family of CO2 Laser Systems, Delivery Devices, and Accessories are as safe and effective as the previously cleared predicate systems (K100415). The subject devices have the same intended use, indications for use, and principles of operation as the predicate devices, and the technological characteristics are nearly identical; the minor technological differences between the cleared and modified laser systems do not raise different questions of safety or effectiveness. In addition, performance data demonstrate that the modified devices perform as intended and comparably to the predicate devices. Thus, the modified AcuPulse Family of CO2 Laser Systems, Delivery Devices, and Accessories are substantially equivalent.

Regulation Number and Section

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.

Indications for Use

510(k) Number (if known)

K180597

Device Name

Indications for Use (Describe)

Podiatry

Otolaryngology (ENT)

Neurosurgery Indications

Dental and Oral Surgery

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510(k) SUMMARY

Intended Use/ Indications for Use:

Dermatology

Podiatry

Otolaryngology (ENT)

Gynecology and GYN Laparoscopy Indications

Neurosurgery Indications

Orthopedic Indication

General and Thoracic Surgery

Dental and Oral Surgery

Device Description / Summary of Technological Characteristics:

Performance Data

Conclusions

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

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