# K151331: The UltraPulse system (UltraPulse and UltraPulse DUO models,members of the modified Lumenis Family of UltraPulse SurgiTouch

- Pathway: 510(k) (Special)
- Applicant: Lumenis, Ltd.
- Decided: Jun 30, 2015 after 42 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K936109 (1994). 26 ancestors in all.
6 later devices descend from it; 4 cite it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030147: Lumenis Family of Ultrapulse Surgitouch CO2 Surgical Lasers, Lumenis, Ltd. (2003) Summary page 9.

## Most influential descendants
- K211362: SCAR 3 (2021), 1 descendant of its own
- K203544: UltraPulse Surgical and Aesthetic CO2 Laser System, Delivery Devices and Accessories (2020), 1 descendant of its own
- K231309: SCAR 3 (2023), 0 descendants of its own
- K213669: Lightscalpel LS-4020 (2023), 0 descendants of its own
- K220467: The Family of UltraPulse CO2 Surgical and Aesthetic Lasers, Delivery Devices and Accessories (2022), 0 descendants of its own

## 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 SurgiTouch CO2 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 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 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 • 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, 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 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

Source page: https://510kreport.com/device/K151331
Methodology: https://510kreport.com/methodology