LogoFDA 510(k) Search
K Number
K180597
Device Name
AcuPulse (previously called AcuPulse 30/40 ST); AcuPulse 40W G; AcuPulse DUO
Manufacturer
Lumenis Ltd.
Date Cleared
2018-04-03

(28 days)

Product Code
GEX
Regulation Number
878.4810
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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, 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.
More Information

K100415

K100384, K130164

No
The summary describes a computer-controlled CO2 laser system for surgical applications. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML functionality. The software is described as proprietary and embedded for control, not for analytical or learning tasks.

Yes
The device is indicated for vaporization, incision, excision, ablation, or photocoagulation of soft tissue in various surgical specialties, which are all therapeutic procedures. The "Summary of Performance Studies" also mentions "therapeutic laser equipment."

No

Explanation: The device is indicated for the "vaporization, incision, excision, ablation or photocoagulation of soft tissue," which are surgical and therapeutic actions, not diagnostic ones.

No

The device description clearly states it is a laser system with physical components like a console, ports, footswitch, and delivery devices. While it uses embedded software for control, it is fundamentally a hardware device.

Based on the provided information, this device is not an In Vitro Diagnostic (IVD).

Here's why:

  • Intended Use: The intended use clearly states that the device is for the "vaporization, incision, excision, ablation or photocoagulation of soft tissue in the surgical specialties". This describes a surgical procedure performed directly on a patient's tissue.
  • Device Description: The device is a CO2 laser system with delivery devices and accessories used for surgical applications. It operates by delivering laser energy to tissue.
  • Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of biological specimens.

The device is a surgical laser system used for treating tissue directly, not for analyzing samples in vitro.

N/A

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, 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

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

  • 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

  • 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

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 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 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

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 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

Product codes (comma separated list FDA assigned to the subject device)

GEX

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Soft tissue

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K100415

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K100384, K130164

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 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.

0

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

1

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

2

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

3

  • 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

4

  • 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

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 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

5

  • 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

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 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

6

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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FOR FDA USE ONLY

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7

510(k) SUMMARY

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

| Applicant Name: | Lumenis Ltd.
6 Hakidma Street PO Box 240
Yokneam Industrial Park,
Yokneam 2069204, Israel
Tel: +972-4-9599000
Fax: +972-4-9599046 |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Amaya De Levie Lumenis Ltd.
6 Hakidma Street PO Box 240,
Yokneam Industrial Park,
Yokneam 2069204, Israel
Tel:+972-4-9599119
Fax +972-4-9599198
email:amaya.de-levie@lumenis.com |
| Date Prepared: | 06 March 2018 |
| Trade Name: | Lumenis AcuPulse Family of CO2 Laser Systems, Delivery Devices and
Accessories (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:

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

8

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

9

  • 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 ●

10

  • . 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)

11

  • 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

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 neurosurgery for the treatment of:

  • . 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

12

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

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 dentistry and oral surgery. Applications include:

  • Gingivectomy/removal of hyperplasias
  • . Gingivoplasty

13

  • 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 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 ●

14

  • . 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.1

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

15

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.