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The UltraPulse Alpha CO2 Laser System, Delivery Devices and Accessories (members of the UltraPulse CO2 Laser Systems Family) are indicated for use in surgical or aesthetic applications requiring: ablation, vaporization, excision, or coagulation of soft tissue in medical specialties including: dermatology and plastic surgery (aesthetic), podiatry , gynecology, general and oral surgery, dental and oral surgery and genitourinary surgery as follows:

The UltraPulse SurgiTouch and UltraPulse Encore CO2 Laser System, Delivery Devices and Accessories (members of the UltraPulse CO2 Laser Systems Family) are indicated for use in surgical or aesthetic applications requiring: ablation, vaporization, excision, or coagulation of soft tissue in medical specialties including: aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (including laparoscopy), neurosurgery, orthopedics (soft tissue), arthroscopy (knee), general and thoracic surgery (including open and endoscopic), dental and oral surgery and genitourinary surgery as follows:

The Lumenis Be Family of UltraPulse CO2 Surgical and Aesthetic Laser Systems, Delivery Devices and Accessories (subject devices) consist of the following devices:

Laser Systems

• o UltraPulse Alpha (also written as UltraPulse α)
• UltraPulse Encore o
• UltraPulse SurgiTouch o

Delivery Devices and Accessories

• o DeepFX Microscanner and disposable tips
• UltraScan CPG Microscanner o
• o TrueSpot 2.0 mm Collimated Handpiece
• o 0.2 mm and 1.0 mm Focused Incisional Handpieces (also called Standard Handpieces)

Each UltraPulse laser system is an advanced computer-controlled device with RF - modulated CO2 laser tube technology that emits laser beams at a wavelength of 10,600 or 11,100 nm. Each has an additional diode laser in the red visible spectrum emitting along the same optical path as the CO2 to serve as an aiming beam.

Attached to each laser system are the delivery devices and accessories that direct the laser beams to the intended treatment site in the format as selected by the user.

This document is a 510(k) premarket notification decision letter from the FDA regarding a CO2 Laser System for surgical and aesthetic applications. It does not contain information about the acceptance criteria or a study proving the device meets those criteria in the context of an AI/algorithm-based medical device.

The document states:

• "For the labeling changes described in the 510(k), no testing was required." (Page 12)
• The entire submission is focused on "labeling changes" and a new manufacturer name, not performance evaluation of a new or modified device functionality that would require clinical or technical studies demonstrating performance metrics.
• The device being cleared is a traditional medical laser system, not an AI or algorithm-based device. Therefore, the concepts of "ground truth," "expert consensus," "training set," "test set," "MRMC study," and "human readers improve with AI assistance" are not applicable to this document.

Therefore, I cannot extract the requested information (acceptance criteria table, sample size, expert information, adjudication methods, MRMC study, standalone performance, ground truth types, training set size, and ground truth establishment for training set) from the provided text. The document pertains to a regulatory clearance based on substantial equivalence for a non-AI device with labeling changes, not a performance study for an AI-enabled device.

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The Modified Lumenis Family of UltraPulse SurgiTouch CO2 Surgical Lasers (and the delivery accessories that are used with them to deliver laser energy) are 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 Modified Lumenis Family of UltraPulse Surgical Lasers are 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). Clinical study demonstrated that skin resurfacing of wrinkles, rhytids, and furrows with the UltraPulse CO2 laser increases the amount of sub-epidermal collagen. 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 telagiectaticum); 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/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: 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 in podiatry for complete and partial matrixectomy.

Otolaryngology (ENT): Laser incision, excision, ablation and/or vaporization of soft tissue in otolaryngology for treatment of: choanal atresia; leukoplakia, including oral, larynx, uvula, palatal, 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 fendoscopic laser-assisted esophagodiverticulostomy (ELAED)]; stenosis, including subglottic stenosis; tonsillectomy (including tonsillar cryptolysis, 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 on 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 (GYN) for treatment of: conization of the cervix, including cervical intraepithelial neoplasia (CIN), vulvar and vaginal intraepithelial neoplasia (VIN, VAIN); condyloma acuminata, including cervical, genital, vulvar, perineal, and Bowen's disease, (Erythroplasia 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 GYN laparoscopy, for treatment of: endometrial lesions, including ablation of endometriosis; excision/lysis of adhesions; salpingostomy; oophorectomy/ovariectomy; fimbroplasty; metroplasty; microsurgery (tubal); uterine myomas and fibroids; ovarian fibromas and follicle cysts; uterosacral ligament ablation; hysterectomy.

Neurosurgery: Laser incision, excision, ablation and/or vaporization of soft tissue in neurosurgery for the treatment of: Cranial: posterior fossa tumors; peripheral neurectomy; benign and malignant tumors and cysts (e.g. gliomas, menigiomas (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.

Orthopedics: Incision/excision and vaporization of soft tissue in orthopedic surgery. Applications include: Arthroscopy: menisectomy; chondromalacia: chondroplasty; ligament release (lateral and other); excision of plica; partial synovectomy. General: debridement of traumatic wounds; debridement of dualifatio woulds; debridement of decubitus and diabetic ulcers; and New; microsurgery; artificial joint revision; PMMA removal.

General/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/Oral Surgery: Incision/excision and vaporization of soft tissue in dentistry and oral surgery. Applications include: gingivectomy- removal of hyperplasias; gingivoplasty: incisional and excisional biopsy; treatment of ulcerous lesions, including aphthous ulcers; incision of infection when used with antibiotic therapy; frenectomy (frenum release); excision and ablation of benign and malignant lesions; homeostasis; operculectomy; crown lengthening; removal of soft tissue, cysts and tumors; oral cavity tumors and hemangiomas; abscesses; extraction site hemostasis; salivary gland pathologies; preprosthetic gum preparation; leukoplakia; partial glossectomy; periodontal gum resection.

Genitourinary: Incision/excision and vaporization of soft tissue in genitourinary procedures. Applications include: benign and malignant lesions of external genitalia; condyloma; phimosis; erythroplasia.

The modified Lumenis family of UltraPulse SurgiTouch CO2 Laser Systems are comprised of the following main components: A laser console. A laser console tower. A counterbalanced articulated arm and delivery system. Control and display panel. System microprocessor control electronics. A covered footswitch or handswitch for specific delivery device accessories. An optional air purge pump system with an insufflator filter for purge of delivery device accessories. Operating software. A variety of delivery device accessories or handpieces, including a pattern generator.

The provided text is a 510(k) summary for the Lumenis Family of UltraPulse SurgiTouch CO2 Laser Systems, which describes the device's indications for use and asserts its substantial equivalence to predicate devices. It does not contain information about specific acceptance criteria or a study proving the device meets particular performance metrics with numerical results.

The document states that "Medical and clinical study information was provided to demonstrate that the modified Lumenis family of UltraPulse SurgiTouch Carbon Dioxide Surgical Lasers are safe and effective," but it does not detail the methodology, results, or acceptance criteria of such studies. It primarily focuses on defining the general surgical applications for which the device is indicated and asserting its equivalence to previously cleared devices.

Therefore, I cannot extract the requested information regarding acceptance criteria, reported performance, sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details from the provided text. The document acts as a regulatory filing summary, emphasizing the device's intended use and its similarity to predicate devices, rather than a detailed performance study report.

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