(42 days)
No
The document describes a CO2 laser system for surgical applications and does not mention any AI or ML components in its description, intended use, or performance testing.
Yes
The device is indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue across various medical specialties, which are therapeutic interventions.
No
The device is a surgical laser system intended for the ablation, vaporization, excision, incision, and coagulation of soft tissue. Its listed uses are all therapeutic surgical procedures, not diagnostic ones.
No
The device description clearly states that the UltraPulse System is a carbon dioxide laser system with physical components like a laser console, articulated arm, footswitch/handswitch, and delivery device accessories. While it mentions proprietary software embedded in controllers, the core functionality and intended use are based on hardware (the laser) for surgical procedures.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical laser system used for the ablation, vaporization, excision, incision, and coagulation of soft tissue in various medical specialties. This involves direct interaction with the patient's body for therapeutic purposes.
- Device Description: The device description details a CO2 laser system with delivery mechanisms (articulated arm, fiber) and accessories for surgical procedures.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening. IVD devices are typically used in laboratories or point-of-care settings for analyzing biological samples.
The UltraPulse system is a surgical device used for treating conditions by physically altering tissue, which falls under the category of therapeutic medical devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The UltraPulse system (UltraPulse and UltraPulse DUO models, members of the modified Lumenis Family of UltraPulse SurgiTouch CO2 Surgical Lasers) is indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (ENT), gynecology (including laparoscopy), neurosurgery, orthopedics (soft tissue), arthroscopy (knee), general and thoracic surgery (including open and endoscopic), dental and oral surgery and genitourinary surgery.
The UltraPulse system (UltraPulse and UltraPulse DUO models, members of the modified Lumenis Family of UltraPulse Surgical Lasers) is indicated for use in the performance of specific surgical applications in aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (ENT), gynecology (including laparoscopy), neurosurgery, orthopedics (soft tissue), arthroscopy (knee), general and thoracic surgery (including open and endoscopic), dental and oral surgery and genitourinary surgery as follows:
Dermatology & Plastic Surgery
The ablation, vaporization, excision, incision, and coagulation of soft tissue in dermatology and plastic surgery in the performance of:
- Laser skin resurfacing ●
- Laser derm-abrasion .
- Laser burn debridement ●
Laser skin resurfacing (ablation and/or vaporization) for treatment of:
-
Wrinkles, rhytids, and furrows (including fine lines and texture irregularities). ●
Laser skin resurfacing (ablation and/or vaporization) of soft tissue for the reduction, removal, and/or treatment of: -
Keratoses, including actinic and seborrheic keratosis, seborrhoecae vulgares, seborrheic ● wart and verruca seborrheica.
-
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
-
. Surqical 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) ●
-
Milia
-
Debridement of eczematous or infected skin ●
-
Basal and squamous cell carcinoma, including keratoacanthomas, Bowen's disease ● (Erythroplasia of Queyrat), and Bowenoid Papulosis (BP) lesions
-
Nevi, including spider, epidermal and protruding .
-
Neurofibromas ●
-
Laser de-epithelialization ●
-
Tricoepitheliomas ●
-
Xanthelasma palpebrarum ●
-
Syringoma ●
Laser ablation, vaporization and/or excision for complete and partial nail matrixectomy.
Vaporization or coagulation of:
- . Benign and malignant vascular/avascular skin lesions
- Moh's Surgery
- Lipectomy ●
- Verrucae and seborrhoecae vulgares, including paronychial, periungal, and subungual ● warts
Laser incision and/or excision of soft tissue for the performance of upper and lower eyelid blepharoplasty.
Laser incision and/or excision of soft tissue for the creation of recipient sites for hair transplantation
Podiatry
Laser ablation, vaporization, and/or excision of soft tissue for the reduction, removal, and/or treatment of:
- . Verrucae vulgares/plantar (warts), including paronychial, periungal and subungual warts
- Porokeratoma ablation
- Ingrown nail treatment ●
- Neuromas/fibromas, including Morton's neuroma ●
- Debridement of ulcers ●
- Other soft tissue lesions ●
Laser ablation, vaporization, and/or excision for complete and partial matrixectomy
Otolaryngology (ENT)
Laser incision, excision, ablation and/or vaporization of soft tissue in otolaryngology for the treatment of:
- . Choanal atresia
- Leukoplakia, including oral, larynx, uvula, palatal, and upper lateral pharyngeal tissue ●
- Nasal obstruction ●
- Adult and juvenile papillomatosis polyps ●
- Polypectomy of nose and nasal passages
- Lymphangioma removal ●
- Removal of vocal cord/fold nodules, polyps and cysts
- Removal of recurrent papillomas in the oral cavity, 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 ● esophaqodiverticulostomy (ELAED))
- Stenosis, including subalottic 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 nondularis chronica . helices/Winkler's disease
- Telangiectasia/hemangioma of larynx, pharynx and trachea (includes uvula, palatal, or ● upper lateral pharyngeal tissue)
- Cordectomy, cordotomy (for the treatment of vocal fold paralysis/vocal fold motion . impairment), and cordal lesions of larynx, pharynx and trachea
- Myringotomy/tympanostomy (tympanic membrane fenestration) ●
- Uvulopalatoplasty (LAUP, laser UPPP) ●
- Turbinectomy and turbinate reduction/ablation ●
- Septal spur ablation/reduction and septoplasty ●
- Partial glossectomy ●
- Tumor resection of oral, subfacial and neck tissues
- Rhinophyma
- Verrucae vulgares (warts) ●
- Gingivoplasty/gingivectomy
Gynecology (GYN)
Laser incision, excision, ablation and/or vaporization of soft tissue in gynecology for the treatment of:
- Conization of the cervix, including cervical intraepithelial neoplasia (CIN), and vulvar and . vaginal intraepithelial neoplasia (VIN, VAIN)
- Condyloma acuminata, including cervical, genital, vulvar, perineal, and Bowen's disease ● (Erythrolasia of Queyrat) and Bowenoid papulosa (BP) lesions
- Leukoplakia (vulvar dystrophies)
- Incision and drainage (I&D) of Bartholin's and nubuthian cysts ●
- Herpes vaporization
- Urethral caruncle vaporization
- Cervical dysplasia ●
- Benign and malignant tumors ●
- Hemangiomas
GYN Laparoscopy
Vaporization, incision, excision, ablation or photocoagulation of soft tissue in endoscopic and laparoscopic surgery, including gynecological laparoscopy, for the treatment of:
- Endometrial lesions, including ablation of endometriosis
- . Excision/lysis adhesions
- Salpingostomy ●
- Oophorectomy/ovariectomy ●
- Fimbrioplasty ●
- Metroplasty
- Microsurgery (tubal) ●
- Uterine myomas and fibroids ●
- Ovarian fibromas and follicle cysts ●
- Uterosacral ligament ablation
- Hvsterectomv ●
Neurosurgery
Laser incision, excision, ablation and/or vaporization of soft tissue in neurosurgery for the treatment of:
Cranial
- . Posterior fossa tumors
- . Peripheral neurectomy
- Benign and malignant tumors and cysts, for example, gliomas, meningiomas (including ● basal tumors), acoustic neuromas, lipomas, and large tumors
- Arteriovenous malformation
- . Pituitary gland tumors (transphenoidal approach)
Spinal cord
- . Incision/excision and vaporization of benign and malignant tumors and cysts
- Intra and extradural lesions ●
- Laminectomy/laminotomy/microdiscectomy ●
Orthopedic
Incision/excision and vaporization of soft tissue in orthopedic surgery, including the following applications:
- . Arthroscopy
- Menisectomy
- Chondromalacia ●
- Chondroplasty ●
- Ligament release (lateral and other) ●
- Excision of plica ●
- Partial synovectomy ●
General
- Debridement of traumatic wounds ●
- Debridement of decubitus and diabetic ulcers
- Microsurgery .
- Artificial joint revision
- PMMA removal .
General and Thoracic Surgery
Incision, excision and vaporization of soft tissue in general and thoracic surgery including endoscopic and open procedures. Applications include:
- Debridement of decubitus ulcers, stasis, diabetic, and other ulcers .
- Mastectomy ●
- Debridement of burns
- Rectal and anal hemorrhoidectomy ●
- Breast biopsy ●
- Reduction mammoplasty .
- Cytoreduction for metastatic disease ●
- Laparotomy and laparoscopic applications ●
- Mediastinal and thoracic lesions and abnormalities ●
- Skin tag vaporization
- Atheroma ●
- Cysts, including sebaceous cysts, pilar cysts, and mucous cysts of the lips .
- Pilonidal cyst removal and repair .
- Abscesses
- Other soft tissue applications ●
Dental and Oral Surgery
Incision/excision and vaporization of soft tissue in dentistry and oral surgery. Applications include:
- . Gingivectomy/removal of hyperplasias
- Gingivoplasty
- Incisional and excisional biopsy ●
- Treatment of ulcerous lesions, including aphthous ulcers ●
- Incision of infection when used with antibiotic therapy ●
- Frenectomy (frenum release)
- . Excision and ablation of benign and malignant lesions
- Homeostasis
- Operculectomy
- Crown lengthening ●
- Removal of soft tissue, cysts and tumors ●
- Oral cavity tumors and hemanqiomas ●
- Abscesses
- Extraction site hemostasis ●
- Salivary gland pathologies
- Preprosthetic gum preparation ●
- Leukoplakia ●
- Partial glossectomy ●
- Periodontal gum resection ●
Genitourinary
Incision/excision and vaporization of soft tissue in genitourinary procedures. Applications include:
- . Benign and malignant lesions of external genitalia
- Condyloma
- Phimosis ●
- . Erythroplasia
Product codes
GEX
Device Description
The UltraPulse System, subject of this submission, is a carbon dioxide laser system based on a Radio Frequency (RF) modulated CO2 laser tube. It is a new member of the UltraPulse SurgiTouch Family of CO2 Laser Systems, Delivery Devices and Accessories, previously cleared under K030147 and manufactured by Lumenis. The UltraPulse System relies on the same fundamental underlying technology of the cleared systems with some modifications as compared to the cleared family members.
The UltraPulse System, subject of this submission, includes two models: the UltraPulse and the UltraPulse DUO. The UltraPulse model delivers laser energy via a Free Beam Port to which an articulated arm and accessories are connected, similarly to the cleared UltraPulse SurgiTouch CO2 Laser Systems (K030147). The UltraPulse DUO model incorporates also a Fiber Port to which a Fiber and accessories are connected, in addition to the Free Beam Port.
Both models of the UltraPulse System, subject of this submission, as well as its cleared UltraPulse SurgiTouch family (K030147), are comprised of the following main components:
- a Laser Console with a Free Beam Port to which a counterbalanced articulated arm is attached
- . a Footswitch or Handswitch
- . a variety of Delivery Device accessories or handpieces, including a scanning pattern generator
The UltraPulse DUO model includes also the following functional elements:
- . a Fiber Port (on the Laser Console) to which a Fiber is attached
- . a variety of Delivery Device accessories or handpieces, including a Fiber Support Arm and Fiber Handpiece Support Arm
The UltraPulse System (both models) is operated and controlled via proprietary SW embedded in the Main controller, Peripheral controller units and PC.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, skin, nail, ear, nose, head, oral cavity, pharynx, trachea, larynx, esophagus, tonsils, bronchial, external genitalia, cervix, vulva, vagina, perineum, urethra, endometrium, salpinx, ovary, uterus, brain, spinal cord, meninges, bone, joint, ligaments, muscle, breast, rectum, anus, dental, gums, salivary glands
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 UltraPulse System (both models) and its substantial equivalence, with respect to safety and effectiveness, to the cleared predicate system. The following activities were performed:
- . Risk analysis
- . Electrical and laser safety and electromagnetic compatibility testing as required to conform to performance standards as follows:
- EN 60825-1: Safety of laser products-Part 1: Equipment classification and O requirements
- EN 60601-2-22: Medical electrical equipment- part 2: particular requirements for o the safety of diagnostic and therapeutic laser equipment.
- EN 60601-1: Medical electrical equipment Part 1 : General requirements for O basic safety and essential performance
- EN 60601-1-2: Medical electrical equipment Part 1-2 : General requirements o for basic safety and essential performance- Collateral standard : Electromagnetic compatibility- requirements and tests
- Software verification and validation
- . Ability of the subject system to withstand variant operation, storage and transportation conditions
- . System testing (e.g., energy measurements, safety controls, emission indicator, DUO switching model, Fiber and Free Beam ports, scanner, aiming beam)
Test results indicated that the subject UltraPulse System (both models) performs in accordance with its requirements and specifications, in similarity to its predicate device. Consequently, the UltraPulse System (both models) was found to perform as well as its predicate, to be as safe and effective for its intended use as its predicate, and is substantially equivalent to its predicate device without raising any new safety and/or effectiveness issues.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/1 description: The image is the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle are three stylized human profiles facing to the right, with flowing lines representing hair or ribbons.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 30, 2015
Lumenis Ltd. Ms. Elissa Burg Quality Assurance & Regulatory Affairs Director 6 Hakidma Street, P.O. Box 240 Yokneam Industrial Park Yokneam 2069204 ISRAEL
Re: K151331
Trade/Device Name: The UltraPulse system (UltraPulse and UltraPulse DUO models, members of the modified Lumenis Family of UltraPulse SurgiTouch CO2 Surgical Lasers) 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: May 31, 2015
Dear Ms. Burg:
Received: June 3, 2015
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 practice, labeling, 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.
1
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Jennifer R. Stevenson -S
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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
The UltraPulse system (UltraPulse DUO models, members of the modified Lumenis Family of UltraPulse SurgTouch CO2 Surgical Lasers)
Indications for Use (Describe)
The UltraPulse system (UltraPulse DUO models, members of the modified Lumenis Family of UltraPulse SurgiTouch CO2 Surgical Lasers) is indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (ENT), gynecology (including laparosopy), neurosurgery, orthopedics (soft tissue), arthroscopy (knee), general and thoracic surgery (including open and endoscopic), dental and oral surgery and genitourinary surgery.
The UltraPulse system (UltraPulse DUO models, members of the modified Lumenis Family of UltraPulse SurgiTouch CO2 Surgical Lasers) is indicated for use in the performance of specific surgical applications in aesthetic (dermatology and plastic surgery), podiaty, otolaryngology (including laparoscopy), neurosurgery, orthopedics (soft tissue), arthroscopy (kne), general and thoracic surgery (including open and endoscopic), dental and oral surgery and genitourinary surgery as follows:
Dermatology & Plastic Surgery
-The ablation, vaporization, excision, incision, and coagulation of soft tissue in dermatology and plastic surgery in the performance of:
- Laser skin resurfacing
- Laser derm-abrasion
- · Laser burn debridement
-Laser skin resurfacing (ablation and/or vaporization) for treatment of:
-
· Wrinkles, rhytids, and furrows (including fine lines and texture irregularities).
-Laser skin resurfacing (ablation and/or vaporization) of soft tissue for the reduction, removal, and/or treatment of: -
Keratoses, including actinic and sebortheic keratosis, sebortheic wart and verruca sebortheic .
-
· 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
FORM FDA 3881 (1/14)
3
· Cutaneous papilloma (skin tags)
- · Milia
- Debridement of eczematous or infected skin
- · Basal and squamous cell carcinoma, including keratoacanthomas, Bowen's disease (Erythroplasia of Queyrat), and Bowenoid Papulosis (BP) lesions
- · Nevi, including spider, epidermal and protruding
- Neurofibromas
- · Laser de-epithelialization
- · Tricoepitheliomas
- Xanthelasma palpebrarum
- Syringoma
-Laser ablation, vaporization and/or excision for complete and partial nail matrixectomy. Vaporization or coagulation of:
- · Benign and malignant vascular/avascular skin lesions
- · Moh's Surgery
- Lipectomy
- Verrucae and seborrhoecae vulgares, including paronychial, periungal, and subungual warts
-Laser incision and/or excision of soft tissue for the performance of upper and lower eyelid blepharoplasty. -Laser incision and/or excision of soft tissue for the creation of recipient sites for hair transplantation
Podiatry
-Laser ablation, vaporization, and/or excision of soft tissue for the reduction, removal, and/or treatment of:
- · Verrucae vulgares/plantar (warts), including paronychial, periungal and subungual warts
- Porokeratoma ablation
- Ingrown nail treatment
- · Neuromas/fibromas, including Morton's neuroma
- Debridement of ulcers
- · Other soft tissue lesions
-Laser ablation, vaporization, and/or excision for complete and partial matrixectomy
Otolaryngology (ENT)
-Laser incision, excision, ablation and/or vaporization of soft tissue in otolaryngology for the treatment of:
- · Choanal atresia
- · Leukoplakia, including oral, larynx, uvula, palatal, and upper lateral pharyngeal tissue
- · Nasal obstruction
- · Adult and juvenile papillomatosis polyps
- Polypectomy of nose and nasal passages
- · Lymphangioma removal
- · Removal of vocal cord/fold nodules, polyps and cysts
· Removal of recurrent papillomas in the oral cavity, larynx, pharynx and trachea, including the uvula. palatal, upper lateral pharyngeal tissue, tongue and vocal cords.
- · Laser/tumor surgery in the larynx, pharynx, nasal, ear and oral structures and tissue
- · Zenker's Diverticulum/pharyngoesophageal diverticulum (endoscopic laser-assisted esophagodiverticulostomy
- (ELAED))
- Stenosis, including subglottic stenosis
- Tonsillectomy (including tonsillar cryptolysis and neoplasma) and tonsil ablation/tonsillotomy
- · Pulmonary bronchial and tracheal lesion removal
4
- · Benign and malignant nodules, tumors and fibromas (larynx, trachea, tracheobronchial/endobronchial)
- · Benign and malignant lesions and fibromas (nose and nasal passages)
- · Benign and malignant tumors and fibromas (oral)
- · Stapedotomy/Stapedectomy
- · Acoustic neuroma in the ear
- · Superficial lesions of the ear, including chondrodermatitis nondularis chronica helices/Winkler's disease
- Telangiectasia/hemangioma of larynx, pharynx and trachea (includes uvula, palatal, or upper lateral pharyngeal tissue)
· Cordectomy, cordotomy (for the treatment of vocal fold motion impairment), and cordal lesions of larynx, pharynx and trachea
- · Myringotomy/tympanostomy (tympanic membrane fenestration)
- · Uvulopalatoplasty (LAUP, laser UPPP)
- · Turbinectomy and turbinate reduction/ablation
- · Septal spur ablation/reduction and septoplasty
- Partial glossectomy
- · Tumor resection of oral, subfacial and neck tissues
- Rhinophyma
- Verrucae vulgares (warts)
- · Gingivoplasty/gingivectomy
Gynecology (GYN)
-Laser incision, excision, ablation and/or vaporization of soft tissue in gynecology for the treatment of:
· Conization of the cervix, including cervical intraepithelial neoplasia (CIN), and vulvar and vaginal intraepithelial neoplasia (VIN. VAIN)
· Condyloma acuminata, including cervical, genital, vulvar, perineal, and Bowen's disease (Erythrolasia of Queyrat) and Bowenoid papulosa (BP) lesions
- Leukoplakia (vulvar dystrophies)
- · Incision and drainage (I&D) of Bartholin's and nubuthian cysts
- · Herpes vaporization
- · Urethral caruncle vaporization
- · Cervical dysplasia
- · Benign and malignant tumors
- · Hemangiomas
GYN Laparoscopy
-
Vaporization, incision, excision, ablation or photocoagulation of soft tissue in endoscopic and laparoscopic surgery, including gynecological laparoscopy, for the treatment of:
-
· Endometrial lesions, including ablation of endometriosis
-
· Excision/lysis adhesions
-
· Salpingostomy
-
Oophorectomy/ovariectomy
-
· Fimbrioplasty
-
Metroplasty
-
· Microsurgery (tubal)
-
Uterine myomas and fibroids
-
Ovarian fibromas and follicle cysts
-
Uterosacral ligament ablation
-
· Hysterectomy
Neurosurgery
5
-Laser incision, excision, ablation and/or vaporization of soft tissue in neurosurgery for the treatment of:
Cranial
- Posterior fossa tumors
- · Peripheral neurectomy
· Benign and malignant tumors and cysts, for example, gliomas (including basal tumors), acoustic neuromas, lipomas, and large tumors
- · Arteriovenous malformation
- · Pituitary gland tumors (transphenoidal approach)
Spinal cord
- · Incision/excision and vaporization of benign and malignant tumors and cysts
- · Intra and extradural lesions
- Laminectomy/laminotomy/microdiscectomy
Orthopedic
-Incision/excision and vaporization of soft tissue in orthopedic surgery, including the following applications:
- Arthroscopy
- · Menisectomy
- Chondromalacia
- Chondroplasty
- · Ligament release (lateral and other)
- Excision of plica
- · Partial synovectomy
General
- Debridement of traumatic wounds
- · Debridement of decubitus and diabetic ulcers
- · Microsurgery
- Artificial joint revision
- PMMA removal
General and Thoracic Surgery
-Incision, excision and vaporization of soft tissue in general and thoracic surgery including endoscopic and open procedures. Applications include:
- · Debridement of decubitus ulcers, stasis, diabetic, and other ulcers
- · Mastectomy
- · Debridement of burns
- Rectal and anal hemorrhoidectomy
- · Breast biopsy
- · Reduction mammoplasty
- Cytoreduction for metastatic disease
- Laparotomy and laparoscopic applications
- · Mediastinal and thoracic lesions and abnormalities
- Skin tag vaporization
- Atheroma
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· Cysts, including sebaceous cysts, pilar cysts, and mucous cysts of the lips
- · Pilonidal cyst removal and repair
- Abscesses
- · Other soft tissue applications
Dental and Oral Surgery
-Incision/excision and vaporization of soft tissue in dentistry and oral surgery. Applications include:
- · Gingivectomy/removal of hyperplasias
- Gingivoplasty
- · Incisional and excisional biopsy
- · Treatment of ulcerous lesions, including aphthous ulcers
- · Incision of infection when used with antibiotic therapy
- · Frenectomy (frenum release)
- · Excision and ablation of benign and malignant lesions
- Homeostasis
- Operculectomy
- · Crown lengthening
- Removal of soft tissue, cysts and tumors
- · Oral cavity tumors and hemangiomas
- Abscesses
- Extraction site hemostasis
- Salivary gland pathologies
- · Preprosthetic gum preparation
- Leukoplakia
- Partial glossectomy
- Periodontal gum resection
Genitourinary
-Incision/excision and vaporization of soft tissue in genitourinary procedures. Applications include:
- · Benign and malignant lesions of external genitalia
- Condyloma
- Phimosis
- · Erythroplasia
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY
Image /page/8/Picture/1 description: The image contains the logo for Lumenis. The logo consists of a stylized letter "L" inside a circle, followed by the word "Lumenis" in a sans-serif font. A registered trademark symbol is located to the upper right of the word Lumenis.
UltraPulse system (UltraPulse and UltraPulse DUO models, members of the modified Lumenis Family of UltraPulse SurgiTouch CO₂ Surgical Lasers)
| 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: | Elissa Burg | |
| Lumenis Ltd. | ||
| 6 Hakidma Street PO Box 240 | ||
| Yokneam Industrial Park, | ||
| Yokneam 2069204, Israel | ||
| Tel: +972-4-9599168 | ||
| elissa.burg@lumenis.com | and/or | |
| Merav Yarmus, Ph.D. | ||
| BioMedical Strategy (2004) Ltd. | ||
| 155 Bialik St. | ||
| Ramat Gan 5252346, Israel | ||
| Tel: +972-3-6123281 | ||
| merav@ebms.co.il | ||
| Date Prepared: | 13 May 2015 | |
| Trade Name: | UltraPulse System (UltraPulse and UltraPulse DUO models, members of the modified Lumenis Family of UltraPulse SurgiTouch CO2 Surgical Lasers) | |
| Classification Name: | Powered laser surgical instrument | |
| Product Code: | GEX | |
| Device Class: | Class II | |
| Regulation Number: | 21 CFR 878.4810 | |
| Panel: | General & Plastic Surgery | |
| Predicate Device: | Lumenis Family of UltraPulse SurgiTouch CO2 Lasers, Delivery Devices and Accessories, cleared under K030147 |
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Intended Use/ Indications for Use:
The UltraPulse system (UltraPulse and UltraPulse DUO models, members of the modified Lumenis Family of UltraPulse SurgiTouch CO2 Surgical Lasers) is indicated for use in surgical applications requiring the ablation, vaporization, incision, and coagulation of soft tissue in medical specialties including: aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (ENT), gynecology (including laparoscopy), neurosurgery, orthopedics (soft tissue), arthroscopy (knee), general and thoracic surgery (including open and endoscopic), dental and oral surgery and genitourinary surgery.
The UltraPulse system (UltraPulse and UltraPulse DUO models, members of the modified Lumenis Family of UltraPulse Surgical Lasers) is indicated for use in the performance of specific surgical applications in aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (ENT), gynecology (including laparoscopy), neurosurgery, orthopedics (soft tissue), arthroscopy (knee), general and thoracic surgery (including open and endoscopic), dental and oral surgery and genitourinary surgery as follows:
Dermatology & Plastic Surgery
The ablation, vaporization, excision, incision, and coagulation of soft tissue in dermatology and plastic surgery in the performance of:
- Laser skin resurfacing ●
- Laser derm-abrasion .
- Laser burn debridement ●
Laser skin resurfacing (ablation and/or vaporization) for treatment of:
-
Wrinkles, rhytids, and furrows (including fine lines and texture irregularities). ●
Laser skin resurfacing (ablation and/or vaporization) of soft tissue for the reduction, removal, and/or treatment of: -
Keratoses, including actinic and seborrheic keratosis, seborrhoecae vulgares, seborrheic ● wart and verruca seborrheica.
-
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
-
. Surqical scars
-
Keloids including acne keloidalis nuchae
-
Hemangiomas (including Buccal, port wine and pyogenic granulomas/granuloma ● pyogenicum/granuloma telangiectaticum)
-
. Tattoos
-
Telangiectasia ●
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- Removal of small skin tumors, including periungual (Koenen) and subungual fibromas ●
- Superficial pigmented lesions ●
- Adenosebaceous hypertrophy or sebaceous hyperplasia ●
- Rhinophyma reduction ●
- Cutaneous papilloma (skin tags) ●
- Milia
- Debridement of eczematous or infected skin ●
- Basal and squamous cell carcinoma, including keratoacanthomas, Bowen's disease ● (Erythroplasia of Queyrat), and Bowenoid Papulosis (BP) lesions
- Nevi, including spider, epidermal and protruding .
- Neurofibromas ●
- Laser de-epithelialization ●
- Tricoepitheliomas ●
- Xanthelasma palpebrarum ●
- Syringoma ●
Laser ablation, vaporization and/or excision for complete and partial nail matrixectomy.
Vaporization or coagulation of:
- . Benign and malignant vascular/avascular skin lesions
- Moh's Surgery
- Lipectomy ●
- Verrucae and seborrhoecae vulgares, including paronychial, periungal, and subungual ● warts
Laser incision and/or excision of soft tissue for the performance of upper and lower eyelid blepharoplasty.
Laser incision and/or excision of soft tissue for the creation of recipient sites for hair transplantation
Podiatry
Laser ablation, vaporization, and/or excision of soft tissue for the reduction, removal, and/or treatment of:
- . Verrucae vulgares/plantar (warts), including paronychial, periungal and subungual warts
- Porokeratoma ablation
- Ingrown nail treatment ●
- Neuromas/fibromas, including Morton's neuroma ●
- Debridement of ulcers ●
- Other soft tissue lesions ●
Laser ablation, vaporization, and/or excision for complete and partial matrixectomy
Otolaryngology (ENT)
Laser incision, excision, ablation and/or vaporization of soft tissue in otolaryngology for the treatment of:
- . Choanal atresia
- Leukoplakia, including oral, larynx, uvula, palatal, and upper lateral pharyngeal tissue ●
- Nasal obstruction ●
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- 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, 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 ● esophaqodiverticulostomy (ELAED))
- Stenosis, including subalottic 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 nondularis chronica . helices/Winkler's disease
- Telangiectasia/hemangioma of larynx, pharynx and trachea (includes uvula, palatal, or ● upper lateral pharyngeal tissue)
- Cordectomy, cordotomy (for the treatment of vocal fold paralysis/vocal fold motion . impairment), and cordal lesions of larynx, pharynx and trachea
- Myringotomy/tympanostomy (tympanic membrane fenestration) ●
- Uvulopalatoplasty (LAUP, laser UPPP) ●
- Turbinectomy and turbinate reduction/ablation ●
- Septal spur ablation/reduction and septoplasty ●
- Partial glossectomy ●
- Tumor resection of oral, subfacial and neck tissues
- Rhinophyma
- Verrucae vulgares (warts) ●
- Gingivoplasty/gingivectomy
Gynecology (GYN)
Laser incision, excision, ablation and/or vaporization of soft tissue in gynecology for the treatment of:
- Conization of the cervix, including cervical intraepithelial neoplasia (CIN), and vulvar and . vaginal intraepithelial neoplasia (VIN, VAIN)
- Condyloma acuminata, including cervical, genital, vulvar, perineal, and Bowen's disease ● (Erythrolasia of Queyrat) and Bowenoid papulosa (BP) lesions
- Leukoplakia (vulvar dystrophies)
- Incision and drainage (I&D) of Bartholin's and nubuthian cysts ●
- Herpes vaporization
- Urethral caruncle vaporization
- Cervical dysplasia ●
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- Benign and malignant tumors ●
- Hemangiomas
GYN Laparoscopy
Vaporization, incision, excision, ablation or photocoagulation of soft tissue in endoscopic and laparoscopic surgery, including gynecological laparoscopy, for the treatment of:
- Endometrial lesions, including ablation of endometriosis
- . Excision/lysis adhesions
- Salpingostomy ●
- Oophorectomy/ovariectomy ●
- Fimbrioplasty ●
- Metroplasty
- Microsurgery (tubal) ●
- Uterine myomas and fibroids ●
- Ovarian fibromas and follicle cysts ●
- Uterosacral ligament ablation
- Hvsterectomv ●
Neurosurgery
Laser incision, excision, ablation and/or vaporization of soft tissue in neurosurgery for the treatment of:
Cranial
- . Posterior fossa tumors
- . Peripheral neurectomy
- Benign and malignant tumors and cysts, for example, gliomas, meningiomas (including ● basal tumors), acoustic neuromas, lipomas, and large tumors
- Arteriovenous malformation
- . Pituitary gland tumors (transphenoidal approach)
Spinal cord
- . Incision/excision and vaporization of benign and malignant tumors and cysts
- Intra and extradural lesions ●
- Laminectomy/laminotomy/microdiscectomy ●
Orthopedic
Incision/excision and vaporization of soft tissue in orthopedic surgery, including the following applications:
- . Arthroscopy
- Menisectomy
- Chondromalacia ●
- Chondroplasty ●
- Ligament release (lateral and other) ●
- Excision of plica ●
- Partial synovectomy ●
General
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- Debridement of traumatic wounds ●
- Debridement of decubitus and diabetic ulcers
- Microsurgery .
- Artificial joint revision
- PMMA removal .
General and Thoracic Surgery
Incision, excision and vaporization of soft tissue in general and thoracic surgery including endoscopic and open procedures. Applications include:
- Debridement of decubitus ulcers, stasis, diabetic, and other ulcers .
- Mastectomy ●
- Debridement of burns
- Rectal and anal hemorrhoidectomy ●
- Breast biopsy ●
- Reduction mammoplasty .
- Cytoreduction for metastatic disease ●
- Laparotomy and laparoscopic applications ●
- Mediastinal and thoracic lesions and abnormalities ●
- Skin tag vaporization
- Atheroma ●
- Cysts, including sebaceous cysts, pilar cysts, and mucous cysts of the lips .
- Pilonidal cyst removal and repair .
- Abscesses
- Other soft tissue applications ●
Dental and Oral Surgery
Incision/excision and vaporization of soft tissue in dentistry and oral surgery. Applications include:
- . Gingivectomy/removal of hyperplasias
- Gingivoplasty
- Incisional and excisional biopsy ●
- Treatment of ulcerous lesions, including aphthous ulcers ●
- Incision of infection when used with antibiotic therapy ●
- Frenectomy (frenum release)
- . Excision and ablation of benign and malignant lesions
- Homeostasis
- Operculectomy
- Crown lengthening ●
- Removal of soft tissue, cysts and tumors ●
- Oral cavity tumors and hemanqiomas ●
- Abscesses
- Extraction site hemostasis ●
- Salivary gland pathologies
- Preprosthetic gum preparation ●
- Leukoplakia ●
- Partial glossectomy ●
- Periodontal gum resection ●
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Genitourinary
Incision/excision and vaporization of soft tissue in genitourinary procedures. Applications include:
- . Benign and malignant lesions of external genitalia
- Condyloma
- Phimosis ●
- . Erythroplasia
Device Description:
The UltraPulse System, subject of this submission, is a carbon dioxide laser system based on a Radio Frequency (RF) modulated CO2 laser tube. It is a new member of the UltraPulse SurgiTouch Family of CO2 Laser Systems, Delivery Devices and Accessories, previously cleared under K030147 and manufactured by Lumenis. The UltraPulse System relies on the same fundamental underlying technology of the cleared systems with some modifications as compared to the cleared family members.
The UltraPulse System, subject of this submission, includes two models: the UltraPulse and the UltraPulse DUO. The UltraPulse model delivers laser energy via a Free Beam Port to which an articulated arm and accessories are connected, similarly to the cleared UltraPulse SurgiTouch CO2 Laser Systems (K030147). The UltraPulse DUO model incorporates also a Fiber Port to which a Fiber and accessories are connected, in addition to the Free Beam Port.
Both models of the UltraPulse System, subject of this submission, as well as its cleared UltraPulse SurgiTouch family (K030147), are comprised of the following main components:
- a Laser Console with a Free Beam Port to which a counterbalanced articulated arm is attached
- . a Footswitch or Handswitch
- . a variety of Delivery Device accessories or handpieces, including a scanning pattern generator
The UltraPulse DUO model includes also the following functional elements:
- . a Fiber Port (on the Laser Console) to which a Fiber is attached
- . a variety of Delivery Device accessories or handpieces, including a Fiber Support Arm and Fiber Handpiece Support Arm
The UltraPulse System (both models) is operated and controlled via proprietary SW embedded in the Main controller, Peripheral controller units and PC.
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Substantial Equivalence
The UltraPulse System (both UltraPulse and UltraPulse DUO models), subject of this submission, is a modification of the Lumenis Family of UltraPulse SurgiTouch CO2 Lasers cleared under K030147. Both UltraPulse models are regarded as additional members to the UltraPulse SurgiTouch CO2 Laser family, Delivery Devices and Accessories. As such they share with the cleared family members, the same intended use and underlying technology. The modifications introduced to the subject UltraPulse System as compared to its cleared family are designed and intended mainly for system modernization and increased user convenience in accordance with market/design inputs.
Performance testing was conducted in order to demonstrate the performance of the UltraPulse System (both models) and its substantial equivalence, with respect to safety and effectiveness, to the cleared predicate system. The following activities were performed:
- . Risk analysis
- . Electrical and laser safety and electromagnetic compatibility testing as required to conform to performance standards as follows:
- EN 60825-1: Safety of laser products-Part 1: Equipment classification and O requirements
- EN 60601-2-22: Medical electrical equipment- part 2: particular requirements for o the safety of diagnostic and therapeutic laser equipment.
- EN 60601-1: Medical electrical equipment Part 1 : General requirements for O basic safety and essential performance
- EN 60601-1-2: Medical electrical equipment Part 1-2 : General requirements o for basic safety and essential performance- Collateral standard : Electromagnetic compatibility- requirements and tests
- Software verification and validation
- . Ability of the subject system to withstand variant operation, storage and transportation conditions
- . System testing (e.g., energy measurements, safety controls, emission indicator, DUO switching model, Fiber and Free Beam ports, scanner, aiming beam)
Test results indicated that the subject UltraPulse System (both models) performs in accordance with its requirements and specifications, in similarity to its predicate device. Consequently, the UltraPulse System (both models) was found to perform as well as its predicate, to be as safe and effective for its intended use as its predicate, and is substantially equivalent to its predicate device without raising any new safety and/or effectiveness issues.