# K212703: AcuPulse CO2 Laser System, Delivery Devices and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Lumenis, Ltd.
- Decided: Oct 19, 2021 after 54 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: 11 generations back to K936109 (1994). 31 ancestors in all.
No later device cites it as a predicate yet.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180597: AcuPulse (previously called AcuPulse 30/40 ST); AcuPulse 40W G; AcuPulse DUO, Lumenis, Ltd. (2018) Summary page 9.
- K201663: AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories, Lumenis, Ltd. (2020) Summary page 9.
- K202428: AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories, Lumenis, Ltd. (2020) Summary page 9.

## Indications for use
The Lumenis modified AcuPulse CO2 Laser System, Delivery Devices and Accessories, 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 modified AcuPulse CO2 Laser System, Delivery Devices and Accessories, 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 modified AcuPulse CO2 Laser System, Delivery Devices and Accessories, 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 - 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/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 modified AcuPulse CO2 Laser System, Delivery Devices and Accessories, 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 modified AcuPulse CO2 Laser System, Delivery Devices and Accessories, 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 - 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) - 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 modified AcuPulse CO2 Laser System, Delivery Devices and Accessories, 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, 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 - Fimbrioplasty - Metroplasty - Microsurgery (tubal) - Uterine myomas and fibroids - Ovarian fibromas and follicle cysts - Uterosacral ligament ablation - Hysterectomy Neurosurgery Indications The Lumenis modified AcuPulse CO2 Laser System, Delivery Devices and Accessories, is indicated for 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 Indication The Lumenis modified AcuPulse CO2 Laser System, Delivery Devices and Accessories, 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 modified AcuPulse CO2 Laser System, Delivery Devices and Accessories, 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 modified AcuPulse CO2 Laser System, Delivery Devices and Accessories, is indicated for the 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 The Lumenis modified AcuPulse Laser System, Delivery Devices and Accessories when used in conjunction with FemTouch and FemX, is indicated for the vaporization, incision, excision, ablation and coagulation of body soft tissue in medical specialties including aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (ENT), gynaecology, neurosurgery, orthopedics, general and thoracic surgery. The use with the scanning unit is indicated for ablative skin resurfacing.

Source page: https://510kreport.com/device/K212703
Methodology: https://510kreport.com/methodology