(42 days)
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
- 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)
- 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
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.
The provided text does not contain information about acceptance criteria for a medical device's performance, nor does it describe a study demonstrating how the device meets such criteria. Instead, the document is a 510(k) premarket notification summary from the FDA for a new laser surgical instrument, the Lumenis UltraPulse system.
The core of the document focuses on:
- Substantial Equivalence: The primary objective of this 510(k) submission is to demonstrate that the new UltraPulse system is substantially equivalent to a previously cleared predicate device (Lumenis Family of UltraPulse SurgiTouch CO2 Lasers, K030147). This means showing that the device is as safe and effective as a legally marketed device and does not raise new questions of safety or effectiveness.
- Indications for Use: A comprehensive list of surgical applications across various medical specialties (dermatology, plastic surgery, podiatry, ENT, gynecology, neurosurgery, orthopedic, general and thoracic surgery, dental and oral surgery, genitourinary surgery) for which the device is indicated.
- Device Description: Details about the two models (UltraPulse and UltraPulse DUO), their components, and how they deliver laser energy.
- Performance Testing (General): A high-level list of tests performed to support substantial equivalence, including risk analysis, electrical and laser safety, electromagnetic compatibility, software verification/validation, and system testing (e.g., energy measurements, safety controls).
It explicitly states: "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."
However, it does not provide:
- A table of specific quantitative acceptance criteria (e.g., "power output must be within X% of target") and the reported performance against those criteria. The performance testing section mentions "energy measurements" and "safety controls" but does not detail the specific metrics, thresholds, or results.
- Specifics of any clinical study used to prove effectiveness or safety in a human population. The testing mentioned is primarily engineering and safety testing.
- Sample sizes for test sets, data provenance, number/qualifications of experts, adjudication methods, or ground truth details as these are typically associated with clinical performance studies, which are not detailed here.
- MRMC comparative effectiveness study or standalone algorithm performance data, as this device is a laser surgical instrument, not an AI/algorithmic diagnostic or assistive tool.
Therefore, an answer based on your requested format for acceptance criteria, study details, and AI-specific information cannot be fully provided from the given text.
If you are looking for an example of a device and study that meets all of your criteria, this document is not suitable as it describes a hardware device's 510(k) submission focused on substantial equivalence to a predicate, not an AI/algorithm-based device with specific clinical performance metrics.
§ 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.