# K141908: Dual Switch - Pathway: 510(k) (Special) - Applicant: Laser Engineering, Inc. - Decided: Oct 22, 2014 after 99 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 No predicates in its family tree. No later device cites it as a predicate yet. 0 of 1 device in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - None. The summary cites one number, which could not be confirmed as its predicate (listed below). ## Cited in the summary but kept off the family tree - K100595: Ecleris Microstar Colposcope, Ecleris USA (2010). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree ## Indications for use The intended use for the Dual Switch Adapter is for the vaporization, incision, excision, ablation, or photocaogulation 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 Dual Switch Adapter 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 Dual Switch Adapter is indicated for use in dermatology and plastic surgery for the following applications: -Ablation, vaporization, excision, and coagulation of soft tissue in the performance of: laser skin resurfacing, laser dermabrasion, and 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, seborrhoecae vulgares, seborrheci wart and verruUT seborrheica. Vermillionectomy of the lip Cutaneous horns Solar/actinic elastosis Cheilis, 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 pygenic granulomas/granuloma 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 papilloma (skin tags) Milia Debridement of eczematous or infected skin Bramous and squamous cell carminoma, 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 Syringoma -Laser ablation, vaporization, and/or excision for complete and partial nail matrixecomy -Vaporization/coagulation of: benign/malignant vascular/avascular skin lesions, Moh's surgery, Lipectomy, Verrucae and seborrhoecae vulgares, including paronychial, periungual 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 receipt sites for hair transplantation Podiatry The Dual Switch Adapter 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, periungual 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 The Dual Switch Adapter 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 Deverticulum/pharyngoesophageal diverticulum) endoscopic laser-assisted esophagodiverticulostomy (ELAED) -Stenosis, including subgottic 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 neuroma in the ear -Superficial lesions of the ear, including chondrodermatatis nondularis chroniUT 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 and turbinate reduction/ablation -Septal spur ablation/reduction and septoplasty -Partial glossectomy -Tumor resection of oral, subfacial and neck tissue -Rhinophyma -Verrucae vulgares (warts) -Gingivoplasty/gingivectomy Gynecology and GYN Laparoscopy Indication The Dual Switch Adapter is indicated for use in gynecology 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) or Bartholin's and nabothian cysts Herpes vaporizaton 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 Dual Switch Adapter is indicated for laser incision, excision, ablation and/or vaporizaton 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 Dual Switch Adapter is indication 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 Dual Switch Adapter 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, 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 -Pilondial cyst removal and repair -Abscesses -Other soft tissue applications Dental and Oral Surgery The Dual Switch Adapter is indication for the incision, excision and vaporization of soft tissue in dentisty 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 -Preproshetic gum preperation -Leukoplakia -Partial glossectomy -Periodental gum resection Source page: https://510kreport.com/device/K141908 Methodology: https://510kreport.com/methodology