# K100415: Acupulse 30/40 ST CO2 Laser System and Acupulse 40WG CO2 Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Lumenis
- Decided: Apr 21, 2010 after 64 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K936109 (1994). 27 ancestors in all.
10 later devices descend from it; 4 cite it directly.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082809: Acupulse 30 and 40 Carbon Dioxide Laser System, Lumenis, Inc. (2008) Summary page 1.

## Most influential descendants
- K180597: AcuPulse (previously called AcuPulse 30/40 ST); AcuPulse 40W G; AcuPulse DUO (2018), 3 descendants of its own
- K132661: Lightscalpel (2014), 3 descendants of its own
- K201663: AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories (2020), 2 descendants of its own
- K141658: Light Scalpel (2014), 2 descendants of its own
- K202428: AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories (2020), 1 descendant of its own

## Recalls of this device
- Sep 25, 2016 · Class II · Z-0301-2017: The cleaning instructions provided in FemTouch Operator's Manual might be ineffective for a fully assembled device and may lead to a potential for cross-contamination.

## Indications for use
The intended use of the AcuPulse 30/40 ST C02 Laser Systems and AcuPulse 4OWG C02 Laser series is 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 AcuPulse series 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 AcuPulse laser 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 debridemnent * 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: - Keratoses, including actinic and seborrheic keratosis, seborrhoecae vulgares, seborrheci wart and verruUT 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 pygnci* pyogenicum/granuloma telangiectaticum) - Tatoos - Telangiectasia - Removal of small skin tumors, including periungual (Koenen) and subungual fibromas - Superficial pigmented lesions - Adenosebaceous hypertrophy or sebaceous hyperplasia - Rhinophyma reduction - Cutaneous papillomna (skin tags) - Milia - Debridement of eczematous or infected skin - Bramnous and sqlarous cell carcinoma,including keratoacanthomas, Bowen's disease (Erythroplasia of Queyrat), and Bowenoid Papulosis (BP) lesions - Nevi, including spider, epidermal and protruding - Neurofibromas - Laser de-epitheliazation - Tricoepitheliomas - Xanthelasma palpebrarum - Syringomna * Laser ablation, vaporization, and/or excision for complete and partial nail matrixecomy * Vaporization/coagulation of: - Benign/malignant vascular/avascular skin lesions - Mob'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 PodiatrV The AcuPulse laser is indicated for use in podiatry 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 Otolarvngolosrv (ENT) The AcuPulse laser 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 * Polypectomny 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 Diver-ticulum/pharyngoesophageaI diverticulumn (endoscopic laser-assisted esophagodiverticulostomy (ELAED)) * Stenosis, including subglottic stenosis * Tonsillectomy (including tonsilar 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 neuiomna in the ear * Superficial lesions of the ear, including chondrodermatitis nondularis chroniUT helices/Winkler's disease * Telangiectasia/hemangioma of larynx, pharynx and trachea (includes uvula, palatal, or upper lateral pharyngeal tissue) * Cordectomny, cordotomy (for the treatment of vocal fold paralysis/vocal fold motion impairment), and cordal lesions of larynx, pharynx and trachea * Myringotomy/tymnpanostomy (tympanic membrane fenestration) * Uvulopalatoplasty (LAUP, laser UPPP) * Turbinectomy and turbinate reduction/ablationKt{ea * 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 AcuPulse laser is indicated for use in gynecology for the followig 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 AcuPulse laser 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 AcuPulse Laser is indication for incision, excision and vaporization of soft tissue in orthopedic surgery, including the following applications: * Arthroscopy - Meniscectorny - Chondromnalacia - 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 Gcneral and Thoracic Surgery The AcuPulse Laser is indication 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, diabeti6, and other ulcers * Mastectomy * Debridement of bums * 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 * Pilondial cyst removal and repair * Abscesses * Other soft tissue applications Dental and Oral Surg~ery The AcuPulse Laser is indication for the incision, excision and vaporization of soft tissue in dentistry and oral surgery. Applications include: * Gingivectomy/removal of hyperplasia~s * Gingivoplasty * lncisional and excisional biopsy * Treatment of ulcerous lesions, including aphthous ulcers * Incision of infection when used with antibiotic therapy * Frenectomy (frenumn release) * Excision and ablation of benign and malignant lesions * H-omneostasis * 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 * Periodental gum resection

Source page: https://510kreport.com/device/K100415
Methodology: https://510kreport.com/methodology